Epicondylitis, Lateral Humeral, Tennis Elbow
Conditions
Keywords
Randomised, Placebo-controlled, double blind, Intervention study, Primary health care
Brief summary
The purpose of this study is to compare the clinical effect of physiotherapy alone or combined with corticosteroid injection in the initial treatment of lateral epicondylitis in a primary care setting. To find the short and long term effect of physiotherapy with Mill's manipulation, deep friction massage and exercise therapy. To ascertain wether the outcome is influenced by corticosteroid injection, which has been shown to be of benefit alone in the short term?
Detailed description
Much has been written about lateral epicondylitis/tennis elbow reflecting the existence of many treatments for the condition. However, there is no consensus as to which treatment gives the best results. Based on the latest meta-studies and reviews from the Cochrane Library, one may conclude that there is evidence of a short-term effect of topical or per oral NSAIDs. The same is true for manipulation and exercise. Corticosteroid injection has also been shown to have short-term effect, but not beyond 6 weeks. Ultrasound has a possible short-term effect based on one meta-analysis. Extra corporeal shock wave therapy does not seem to be effective. The treatment with acupuncture, orthosis, surgery or long-term NSAIDs has no support in the literature, and it is impossible to draw any conclusions about the effects or absence thereof. In fact, there is scant support for any long-term treatment in the literature. We have found two studies to be of special interest (see citations below). Both have been done in a primary care setting with one-year follow up. One study compares corticosteroid injection with physical therapy (ultrasound, manipulation and exercise) and a wait-and-see group. The other compares corticosteroid injection with naproxen orally and placebo-medication. Both conclude that corticosteroid injection is a safe and effective treatment as pain-relief during the first 6 weeks, and that the effect of this treatment is better than physical therapy, wait-and-see and naproxen orally within the same time-frame. Physical therapy in one study gives some, but not statistically significantly better long-term (one year) effect than wait-and-see treatment. There seems to be some indication that corticosteroid injection is a good alternative for the first 6 weeks. We find there is a good reason to investigate the long-term effects of physical therapy. At the same time, it would be interesting to see whether the good initial response from corticosteroid injection may be extended if combined with physiotherapy. This randomised, placebo-controlled study will be conducted in general practice in the town of Sarpsborg, Ostfold County, Norway including patient aged 18-70 years with pain of recent onset from the lateral part of the elbow. After a treatment-period of 6 weeks, the patient is followed for a total of 12 months. Patients are recruited by interested general practitioners in the city of Sarpsborg and surroundings and remitted to two study-physicians who make the initial evaluation of inclusion- and exclusion criteria, as well as treatment, follow-up and outcome assessments during the whole study-period. The patients are treated by one of the two study-physicians in the 6-weeks treatment-period. From the 6. week, the patient sees the other physician, who is unaware of the allocated intervention, for further registration and assessment.
Interventions
DRUGtriamcinolone
Injection with triamcinolone 10 mg at start and at 3 weeks
DRUGPlacebo
Injection with sodium chloride at start and at 3 weeks
DRUGLidocaine
10 mg of lidocaine at start and at 3 weeks
OTHERPhysiotherapy
12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
DRUGNaproxen
Naproxen 500 mg bid for 14 days
Sponsors
Allmennmedisinsk forskningsfond, Norway
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 years * Pain from the lateral part of the elbow * The pain increases on resisted dorsiflexion of the wrist with the elbow extended and the fingers flexed or the pain increases on resisted radial deviation of the wrist or the pain increases on resisted extension of the 3. finger
Exclusion criteria
* Duration of complaints less than 2 weeks or more than 3 months * The tenderness is located within the muscle body itself in the proximal part of the short radial extensors muscle of the wrist (Cyriax type IV)9. * Treatment within the last 12 months for the same condition with corticosteroid injection or physiotherapy * Bilateral complaints * Previous surgical treatment for lateral epicondylitis * Deformities of the elbow (congenital or acquired) * Cervical radiculopathy or referred pain from neck or shoulder * Previous fractures or tendon ruptures in the elbow * Systemic musculoskeletal disease * Previous allergic reactions to corticosteroids or lidocaine * Contraindications to corticosteroids or NSAIDs: * On-going or previous gastro-intestinal bleeding * previous ulcer or dyspepsia, severe asthma * on-going systemic infection * local skin-infection * recently vaccinated with live virus * coagulopathies * systemic lupus erythematodes * severe liver- or kidney-disease * heart failure * diabetes * use of warfarin or NSAIDS * Pregnancy or breast-feeding * Fertile females not on effective birth control * Psycho-social or other reasons for not being able to participate throughout the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success - Event Rates in Each Group | 6 - 52 weeks | Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). | 12 weeks | Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. |
| Pain as Recorded by the Study Doctors on a 100 mm VAS-scale | 52 weeks | Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. |
| Pain-free Grip Strength Ratio | 6 weeks | Pain free grip strength registered with hand held dynamometer . Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. |
| Maximum Grip Strength Ratio | 6 weeks | Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. |
| Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors | 6 weeks | To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. |
| Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale) | 6 weeks | Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. |
| Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 6 weeks | Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. |
| Pain Free Function Index of Everyday Activities | 6 weeks | Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. |
| No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 6 weeks | Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain. |
| No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 6 weeks | Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain. |
| Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors | 52 weeks | To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Corticosteroid Injection in Combination With Physical Therapy Corticosteroid injection in combination with physical therapy
Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days
triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks
Lidocaine: 10 mg of lidocaine at start and at 3 weeks
Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
Naproxen: Naproxen 500 mg bid for 14 days | 59 |
| Placebo Injection in Combination With Physical Therapy Placebo injection in combination with physical therapy
Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days
Placebo: Injection with sodium chloride at start and at 3 weeks
Lidocaine: 10 mg of lidocaine at start and at 3 weeks
Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
Naproxen: Naproxen 500 mg bid for 14 days | 58 |
| Control Group: Wait-and-see Treatment Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days
Naproxen: Naproxen 500 mg bid for 14 days | 60 |
| Total | 177 |
Baseline characteristics
| Characteristic | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment | Total |
|---|---|---|---|---|
| Age, Continuous | 47.9 years STANDARD_DEVIATION 9.6 | 48.8 years STANDARD_DEVIATION 9.4 | 44.0 years STANDARD_DEVIATION 9.7 | 46.9 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment Norway | 59 participants | 58 participants | 60 participants | 177 participants |
| Sex: Female, Male Female | 26 Participants | 20 Participants | 25 Participants | 71 Participants |
| Sex: Female, Male Male | 33 Participants | 38 Participants | 35 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 59 | 5 / 58 | 10 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 58 | 0 / 60 |
Outcome results
Primary
Treatment Success - Event Rates in Each Group
Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval.
Time frame: 6 - 52 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Treatment Success - Event Rates in Each Group | 6 weeks | 15 percentage of participants |
| Control Group: Wait-and-see Treatment | Treatment Success - Event Rates in Each Group | 12 weeks | 48 percentage of participants |
| Control Group: Wait-and-see Treatment | Treatment Success - Event Rates in Each Group | 26 weeks | 67 percentage of participants |
| Control Group: Wait-and-see Treatment | Treatment Success - Event Rates in Each Group | 52 weeks | 78 percentage of participants |
| Placebo Injection in Combination With Physical Therapy | Treatment Success - Event Rates in Each Group | 52 weeks | 78 percentage of participants |
| Placebo Injection in Combination With Physical Therapy | Treatment Success - Event Rates in Each Group | 6 weeks | 24 percentage of participants |
| Placebo Injection in Combination With Physical Therapy | Treatment Success - Event Rates in Each Group | 26 weeks | 69 percentage of participants |
| Placebo Injection in Combination With Physical Therapy | Treatment Success - Event Rates in Each Group | 12 weeks | 45 percentage of participants |
| Corticosteroid Injection in Combination With Physical Therapy | Treatment Success - Event Rates in Each Group | 52 weeks | 75 percentage of participants |
| Corticosteroid Injection in Combination With Physical Therapy | Treatment Success - Event Rates in Each Group | 12 weeks | 42 percentage of participants |
| Corticosteroid Injection in Combination With Physical Therapy | Treatment Success - Event Rates in Each Group | 26 weeks | 42 percentage of participants |
| Corticosteroid Injection in Combination With Physical Therapy | Treatment Success - Event Rates in Each Group | 6 weeks | 59 percentage of participants |
Secondary
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
Time frame: 6 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors | 25 mm | Standard Deviation 23 |
| Placebo Injection in Combination With Physical Therapy | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors | 45 mm | Standard Deviation 24 |
| Corticosteroid Injection in Combination With Physical Therapy | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors | 38 mm | Standard Deviation 26 |
Secondary
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
Time frame: 26 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors | 28 mm | Standard Deviation 25 |
| Placebo Injection in Combination With Physical Therapy | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors | 17 mm | Standard Deviation 22 |
| Corticosteroid Injection in Combination With Physical Therapy | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors | 16 mm | Standard Deviation 20 |
Secondary
Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
Time frame: 12 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors | 37 mm | Standard Deviation 29 |
| Placebo Injection in Combination With Physical Therapy | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors | 32 mm | Standard Deviation 25 |
| Corticosteroid Injection in Combination With Physical Therapy | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors | 34 mm | Standard Deviation 28 |
Secondary
Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
Time frame: 52 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors | 16 mm | Standard Deviation 22 |
| Placebo Injection in Combination With Physical Therapy | Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors | 9 mm | Standard Deviation 15 |
| Corticosteroid Injection in Combination With Physical Therapy | Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors | 10 mm | Standard Deviation 17 |
Secondary
Maximum Grip Strength Ratio
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
Time frame: 6 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Maximum Grip Strength Ratio | 87 Ratio x 100 | Standard Deviation 26 |
| Placebo Injection in Combination With Physical Therapy | Maximum Grip Strength Ratio | 80 Ratio x 100 | Standard Deviation 25 |
| Corticosteroid Injection in Combination With Physical Therapy | Maximum Grip Strength Ratio | 74 Ratio x 100 | Standard Deviation 27 |
Secondary
Maximum Grip Strength Ratio
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
Time frame: 12 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Maximum Grip Strength Ratio | 83 Ratio x 100 | Standard Deviation 29 |
| Placebo Injection in Combination With Physical Therapy | Maximum Grip Strength Ratio | 88 Ratio x 100 | Standard Deviation 23 |
| Corticosteroid Injection in Combination With Physical Therapy | Maximum Grip Strength Ratio | 89 Ratio x 100 | Standard Deviation 28 |
Secondary
Maximum Grip Strength Ratio
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
Time frame: 52 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Maximum Grip Strength Ratio | 96 Ratio x 100 | Standard Deviation 19 |
| Placebo Injection in Combination With Physical Therapy | Maximum Grip Strength Ratio | 102 Ratio x 100 | Standard Deviation 17 |
| Corticosteroid Injection in Combination With Physical Therapy | Maximum Grip Strength Ratio | 104 Ratio x 100 | Standard Deviation 15 |
Secondary
Maximum Grip Strength Ratio
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
Time frame: 26 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Maximum Grip Strength Ratio | 89 Ratio x 100 | Standard Deviation 27 |
| Placebo Injection in Combination With Physical Therapy | Maximum Grip Strength Ratio | 99 Ratio x 100 | Standard Deviation 20 |
| Corticosteroid Injection in Combination With Physical Therapy | Maximum Grip Strength Ratio | 99 Ratio x 100 | Standard Deviation 19 |
Secondary
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Time frame: 12 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group: Wait-and-see Treatment | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 22 percentage of patients |
| Placebo Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 12 percentage of patients |
| Corticosteroid Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 17 percentage of patients |
Secondary
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Time frame: 6 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group: Wait-and-see Treatment | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 36 percentage of participants |
| Placebo Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 3 percentage of participants |
| Corticosteroid Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 8 percentage of participants |
Secondary
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Time frame: 52 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group: Wait-and-see Treatment | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 36 percentage of patients |
| Placebo Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 60 percentage of patients |
| Corticosteroid Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 50 percentage of patients |
Secondary
No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Time frame: 26 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group: Wait-and-see Treatment | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 19 percentage of patients |
| Placebo Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 29 percentage of patients |
| Corticosteroid Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist | 38 percentage of patients |
Secondary
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Time frame: 6 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group: Wait-and-see Treatment | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 44 percentage of patients |
| Placebo Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 16 percentage of patients |
| Corticosteroid Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 17 percentage of patients |
Secondary
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Time frame: 52 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group: Wait-and-see Treatment | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 53 percentage of patients |
| Placebo Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 76 percentage of patients |
| Corticosteroid Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 63 percentage of patients |
Secondary
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Time frame: 12 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group: Wait-and-see Treatment | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 36 percentage of patients |
| Placebo Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 24 percentage of patients |
| Corticosteroid Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 22 percentage of patients |
Secondary
No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Time frame: 26 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group: Wait-and-see Treatment | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 31 percentage of patients |
| Placebo Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 53 percentage of patients |
| Corticosteroid Injection in Combination With Physical Therapy | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger | 58 percentage of patients |
Secondary
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
Time frame: 26 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 36 mm | Standard Deviation 26 |
| Placebo Injection in Combination With Physical Therapy | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 19 mm | Standard Deviation 23 |
| Corticosteroid Injection in Combination With Physical Therapy | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 18 mm | Standard Deviation 20 |
Secondary
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
Time frame: 6 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 32 mm | Standard Deviation 26 |
| Placebo Injection in Combination With Physical Therapy | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 50 mm | Standard Deviation 26 |
| Corticosteroid Injection in Combination With Physical Therapy | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 51 mm | Standard Deviation 28 |
Secondary
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
Time frame: 12 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 43 mm | Standard Deviation 30 |
| Placebo Injection in Combination With Physical Therapy | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 35 mm | Standard Deviation 28 |
| Corticosteroid Injection in Combination With Physical Therapy | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 36 mm | Standard Deviation 27 |
Secondary
Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
Time frame: 52 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 20 mm | Standard Deviation 24 |
| Placebo Injection in Combination With Physical Therapy | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 9 mm | Standard Deviation 13 |
| Corticosteroid Injection in Combination With Physical Therapy | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors | 12 mm | Standard Deviation 19 |
Secondary
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
Time frame: 52 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale | 19 mm | Standard Deviation 23 |
| Placebo Injection in Combination With Physical Therapy | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale | 9 mm | Standard Deviation 11 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale | 13 mm | Standard Deviation 19 |
Secondary
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
Time frame: 12 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). | 41 mm | Standard Deviation 26 |
| Placebo Injection in Combination With Physical Therapy | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). | 33 mm | Standard Deviation 26 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). | 33 mm | Standard Deviation 26 |
Secondary
Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
Time frame: 26 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). | 38 mm | Standard Deviation 28 |
| Placebo Injection in Combination With Physical Therapy | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). | 21 mm | Standard Deviation 22 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). | 19 mm | Standard Deviation 22 |
Secondary
Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
Time frame: 6 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale) | 29 mm | Standard Deviation 25 |
| Placebo Injection in Combination With Physical Therapy | Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale) | 45 mm | Standard Deviation 23 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale) | 44 mm | Standard Deviation 25 |
Secondary
Pain Free Function Index of Everyday Activities
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
Time frame: 6 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain Free Function Index of Everyday Activities | 2.78 score on a scale | Standard Deviation 2.22 |
| Placebo Injection in Combination With Physical Therapy | Pain Free Function Index of Everyday Activities | 4.40 score on a scale | Standard Deviation 2.01 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain Free Function Index of Everyday Activities | 4.82 score on a scale | Standard Deviation 2.16 |
p-value: <0.01linear generalized estimating equations
p-value: <0.01linear generalized estimating equations
Secondary
Pain Free Function Index of Everyday Activities
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
Time frame: 12 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain Free Function Index of Everyday Activities | 3.42 score on a scale | Standard Deviation 2.63 |
| Placebo Injection in Combination With Physical Therapy | Pain Free Function Index of Everyday Activities | 3.62 score on a scale | Standard Deviation 2.43 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain Free Function Index of Everyday Activities | 3.37 score on a scale | Standard Deviation 2.36 |
Secondary
Pain Free Function Index of Everyday Activities
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
Time frame: 26 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain Free Function Index of Everyday Activities | 2.97 score on a scale | Standard Deviation 2.53 |
| Placebo Injection in Combination With Physical Therapy | Pain Free Function Index of Everyday Activities | 1.83 score on a scale | Standard Deviation 2.08 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain Free Function Index of Everyday Activities | 2.00 score on a scale | Standard Deviation 2.25 |
Secondary
Pain Free Function Index of Everyday Activities
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
Time frame: 52 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain Free Function Index of Everyday Activities | 1.64 score on a scale | Standard Deviation 2.04 |
| Placebo Injection in Combination With Physical Therapy | Pain Free Function Index of Everyday Activities | 1.03 score on a scale | Standard Deviation 1.67 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain Free Function Index of Everyday Activities | 1.40 score on a scale | Standard Deviation 1.9 |
Secondary
Pain-free Grip Strength Ratio
Pain free grip strength registered with hand held dynamometer . Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
Time frame: 6 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain-free Grip Strength Ratio | 58 Ratio x 100 | Standard Deviation 35 |
| Placebo Injection in Combination With Physical Therapy | Pain-free Grip Strength Ratio | 50 Ratio x 100 | Standard Deviation 29 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain-free Grip Strength Ratio | 57 Ratio x 100 | Standard Deviation 32 |
Secondary
Pain-free Grip Strength Ratio
Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
Time frame: 52 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain-free Grip Strength Ratio | 100 Ratio x 100 | Standard Deviation 33 |
| Placebo Injection in Combination With Physical Therapy | Pain-free Grip Strength Ratio | 90 Ratio x 100 | Standard Deviation 23 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain-free Grip Strength Ratio | 91 Ratio x 100 | Standard Deviation 23 |
Secondary
Pain-free Grip Strength Ratio
Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
Time frame: 26 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain-free Grip Strength Ratio | 82 Ratio x 100 | Standard Deviation 48 |
| Placebo Injection in Combination With Physical Therapy | Pain-free Grip Strength Ratio | 76 Ratio x 100 | Standard Deviation 27 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain-free Grip Strength Ratio | 74 Ratio x 100 | Standard Deviation 37 |
Secondary
Pain-free Grip Strength Ratio
Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
Time frame: 12 weeks
Population: Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Wait-and-see Treatment | Pain-free Grip Strength Ratio | 64 Ratio x 100 | Standard Deviation 43 |
| Placebo Injection in Combination With Physical Therapy | Pain-free Grip Strength Ratio | 55 Ratio x 100 | Standard Deviation 25 |
| Corticosteroid Injection in Combination With Physical Therapy | Pain-free Grip Strength Ratio | 63 Ratio x 100 | Standard Deviation 36 |