Carpal Tunnel Syndrome
Conditions
Brief summary
Between 2008 and 2012 the investigators performed a single-center randomized double-blind placebo-controlled trial to assess the efficacy of local injection of two different doses of methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18 to 70 years, not previously treated with steroid injection. The primary outcomes were change in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3 groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the 1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.
Detailed description
Extended follow-up protocol: All 111 trial participants will be contacted by telephone by a researcher and given information about this extended follow-up. A questionnaire together with written information and consent forms will be sent by mail. The questionnaire consists of the CTS symptom severity sale, 11-item DASH scale, bodily pain scale, and a treatment satisfaction visual analog scale (VAS), that were used in previous follow-up evaluations. The questionnaire will also include the 6-item CTS symptoms scale (CTS-6) and the palmar pain scale. The patients will be asked whether and when they had undergone carpal tunnel release surgery on the study hand after they received the injection within the trial. Patients' records will be reviewed to verify data about subsequent surgery on the study hand. The Chi-square test will be used to compare the 80-mg methylprednisolone group and the placebo group with regard to the proportion of patients who have had carpal tunnel release surgery on the study hand within 5 years after injection (primary outcome). The change in symptom severity score in patients in the 80-mg methylprednisolone group who did not have surgery on the study hand after injection will be compared with the change in symptom severity score in patients who had surgery on the study hand after methylprednisolone injection (co-primary outcome) using analysis of covariance (ANCOVA) adjusting for sex, age, dominance of the study hand and baseline symptom severity score. A similar comparison will be made for the 11-item DASH and the bodily pain scores. The palmar pain score at 5 to 7 years will be compared between the groups using the independent-samples t-test and also ANCOVA to adjust for sex, age and dominance of the study hand. Patients who had surgery after methylprednisolone injection will be compared with patients who had surgery after placebo injection with regard to change from baseline to 5 to 7 years in the symptom severity score, 11-item DASH scale score, bodily pain score and satisfaction score using ANCOVA adjusting for sex, age, dominance of the study hand and respective baseline score. To identify potential predictive factors for long-term benefit after 80 mg methylprednisolone injection, surgery within 5 years will be analyzed according to the variables sex, age, dominance of the study hand, baseline symptom severity score (≥3 versus \< 3) and baseline median nerve conduction abnormality (severe/moderate vs mild/normal). All statistical tests will be 2-sided and a p value of less than 0.05 will indicate statistical significance.
Interventions
2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
OTHERSaline
2 mL saline + 1 mL lidocaine
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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
* Primary idiopathic CTS * Symptoms of classic or probable CTS according to the Katz diagnostic criteria (numbness and/or tingling in at least 2 of the 4 median nerve innervated fingers) * Failed treatment with wrist splinting (2 months) * Nerve conduction tests showing median neuropathy at the wrist or, if normal, two orthopedic surgeons independently make CTS diagnosis * Symptom severity that warranted referral for consideration for surgery
Exclusion criteria
* Previous steroid injection for CTS * Thenar muscle atrophy * Sensory deficit (two-point discrimination \>8 mm) * Diabetes, thyroid disorder, or inflammatory disease * Polyneuropathy or vibration-induced neuropathy * Current pregnancy * Previous carpal tunnel surgery on the study hand * Surgery on the contralateral hand in the past 2 months * Inability to respond to questionnaires * Severe medical illness * Known drug/alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand | 5 to 7 years | Number of patients who have had carpal tunnel release surgery on the study hand. |
| Symptom Severity Score | 5-7 years | Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Palmar Pain Score | 5-7 years | Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best). |
| 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score | 5-7 years | Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst) |
| Bodily Pain Score | 5-7 years | Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best). |
| Satisfaction Score | 5-7 years | Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best). |
Participant flow
Recruitment details
This is a long-term follow-up of patients who participated in a randomized trial. In the initial trial the patients were recruited between November 7, 1998 and March 10, 2011 (NCT00806871; see Atroshi et al. Ann Intern Med 2013). Data in this follow-up were collected between February 24, 2016 and July 7, 2016.
Pre-assignment details
No significant events occurred after participant enrollment but prior to assignment to arms.
Participants by arm
| Arm | Count |
|---|---|
| Methylprednisolone 80 mg Local injection of 80 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine | 37 |
| Methylprednisolone 40 mg Local injection of 40 mg Methylprednisolone into the carpal tunnel
Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine | 37 |
| Placebo Local injection of saline into the carpal tunnel
Saline: 2 mL saline + 1 mL lidocaine | 37 |
| Total | 111 |
Baseline characteristics
| Characteristic | Methylprednisolone 40 mg | Total | Methylprednisolone 80 mg | Placebo |
|---|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 11 | 53 years STANDARD_DEVIATION 12 | 53 years STANDARD_DEVIATION 12 | 55 years STANDARD_DEVIATION 12 |
| Body mass index | 27.6 kg/m2 STANDARD_DEVIATION 4.3 | 27.5 kg/m2 STANDARD_DEVIATION 4.8 | 27.3 kg/m2 STANDARD_DEVIATION 4.2 | 27.7 kg/m2 STANDARD_DEVIATION 5.7 |
| Dominant hand treated | 29 Participants | 87 Participants | 30 Participants | 28 Participants |
| Follow-up time from randomization/treatment | 74 months STANDARD_DEVIATION 7.1 | 74 months STANDARD_DEVIATION 7.2 | 74 months STANDARD_DEVIATION 7.5 | 74 months STANDARD_DEVIATION 7.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 111 Participants | 37 Participants | 37 Participants |
| Region of Enrollment Sweden | 37 participants | 111 participants | 37 participants | 37 participants |
| Sex: Female, Male Female | 27 Participants | 81 Participants | 26 Participants | 28 Participants |
| Sex: Female, Male Male | 10 Participants | 30 Participants | 11 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 0 / 37 | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 | 0 / 37 |
Outcome results
Primary
Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand
Number of patients who have had carpal tunnel release surgery on the study hand.
Time frame: 5 to 7 years
Population: Data from all trial participants were available with no withdrawals, drop-outs or missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methylprednisolone 80 mg | Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand | 31 Participants |
| Methylprednisolone 40 mg | Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand | 34 Participants |
| Placebo | Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand | 36 Participants |
Primary
Symptom Severity Score
Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms).
Time frame: 5-7 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylprednisolone 80 mg | Symptom Severity Score | 1.34 score on a scale | Standard Deviation 0.9 |
| Methylprednisolone 40 mg | Symptom Severity Score | 1.53 score on a scale | Standard Deviation 0.9 |
Secondary
11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score
Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst)
Time frame: 5-7 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylprednisolone 80 mg | 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score | 13.1 score on a scale | Standard Deviation 18 |
| Methylprednisolone 40 mg | 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score | 16.9 score on a scale | Standard Deviation 20 |
| Placebo | 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score | 19.3 score on a scale | Standard Deviation 20 |
Secondary
Bodily Pain Score
Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best).
Time frame: 5-7 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylprednisolone 80 mg | Bodily Pain Score | 81.4 score on a scale | Standard Deviation 24 |
| Methylprednisolone 40 mg | Bodily Pain Score | 79.9 score on a scale | Standard Deviation 24 |
| Placebo | Bodily Pain Score | 78.2 score on a scale | Standard Deviation 25 |
Secondary
Palmar Pain Score
Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best).
Time frame: 5-7 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylprednisolone 80 mg | Palmar Pain Score | 86.4 score on a scale | Standard Deviation 18 |
| Methylprednisolone 40 mg | Palmar Pain Score | 84.6 score on a scale | Standard Deviation 22 |
| Placebo | Palmar Pain Score | 83.0 score on a scale | Standard Deviation 25 |
Secondary
Satisfaction Score
Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best).
Time frame: 5-7 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylprednisolone 80 mg | Satisfaction Score | 77.5 score on a scale | Standard Deviation 28 |
| Methylprednisolone 40 mg | Satisfaction Score | 71.4 score on a scale | Standard Deviation 27 |
| Placebo | Satisfaction Score | 68.4 score on a scale | Standard Deviation 28 |