Myofacial Pain Syndromes, Plantar Fascitis, Trigger Point Pain, Myofascial
Conditions
Brief summary
This is a clinical trial that will be done in the state of Kuwait, at the physical rehabilitation medicine hospital. the participants will be recruited from all over Kuwait, there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of health.
Detailed description
Physical therapy approaches continue evolving. During the last years, minimally invasive techniques such as percutaneous needle electrolysis (PNE) was being developed, obtaining promising results for tendon pathology. PNE technique is a minimally invasive treatment that consists of an application of a galvanic electrolytic current that causes a controlled local inflammatory process in the target tissue. This allows for phagocytosis and the subsequent regeneration of the affected tissue. Nowadays, PNE is being used in clinical practice to manage MTrP, but there are no studies supporting that they have an additional beneficial effect over DN. From a biological point of view, it seems reasonable to ascertain that a patient will obtain benefits thanks to the mechanical effects provided by the needle and that patients may benefit more if the electrolysis effect is added to the mechanical stimuli provided by the needle. Therefore, the aim of this randomized controlled study is to compare the effectiveness of DN versus PNE for the level of pain in patients suffering from PHP.
Interventions
OTHERdry needling
The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
Sponsors
Universidad San Jorge
Ministry of Health, Kuwait
Universidad de Zaragoza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants who fulfill the inclusion criteria will receive the standardized oral and written information, and, once they consent to participate in the trial, will be randomized in a block system by blocks of 10 patients. Allocation to the groups will be achieved using a computer program (Randomizer, https://www.randomizer.org/) generated a random patient file numbers sequence by a third person not involved in the study from the file section in Kuwait. This person will be responsible for guarding the envelope with the information of the randomization. The envelopes will be closed until the moment of the intervention to maintain the blinding. This professional also will ask the patients for informed consent. The consent form is recruited upon the ethical medical committee at the ministry of health in the state of Kuwait.
Intervention model description
This study is a prospective, two parallel-groups (participant) randomized controlled trial with blinded outcome assessment at baseline, and at 4, 8, 12, 26 and 52 weeks. The study flow chart shown in Figure 1 conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for nonpharmacological studies
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of PHP in accordance with the Clinical Guidelines linked to the International Classification of Function, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association * Age greater than 21 years according to the Kuwaiti law. * History of plantar heel pain for greater than one month. * Walking 50 meters without any support * Having MTPs on initial physical examination on plantar and calf muscles * Accepting to be treated by a male physiotherapist. * Capacity to understand the study and the informed consent, as well as having signed the document.
Exclusion criteria
* \- Needle phobia * Allergy from needles or hypersensitivity to metals * Presence of coagulopathy or use of anticoagulants * Presence of peripheral arterial vascular disease * Pregnancy * Dermatological disease with the dry needling area * The presence of a chronic medical condition that might preclude participation in the study such as malignancy, systemic inflammatory disorders (e.g. psoriatic arthritis, ankylosing spondylitis, septic arthritis), neurological diseases, polyneuropathy, mononeuropathy. * Treatment of plantar heel pain with needling or acupuncture during last 4 weeks. * A history of injection therapy in the heel in the previous three months. * Previous history of foot surgery or fracture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foot Health Status Questioner (FHSQ) PAIN | Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks | Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Maximum | 1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4) | Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable |
| The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks | The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL. |
Countries
Kuwait
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dry Needling (DN) Arm Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. | 51 |
| Percutaneous Needle Electrolysis (PNE) Arm The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. | 51 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 21 |
Baseline characteristics
| Characteristic | Dry Needling (DN) Arm | Percutaneous Needle Electrolysis (PNE) Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 51 Participants | 102 Participants |
| Age, Continuous | 49.5 years STANDARD_DEVIATION 8.9 | 48.1 years STANDARD_DEVIATION 8.8 | 48.8 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 51 Participants | 51 Participants | 102 Participants |
| Region of Enrollment Kuwait | 51 Participants | 51 Participants | 102 Participants |
| Sex: Female, Male Female | 36 Participants | 36 Participants | 72 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 9 / 51 | 14 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
Foot Health Status Questioner (FHSQ) PAIN
Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | baseline | 38.8 score on a scale | Standard Deviation 18.8 |
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | 4 weeks | 73.4 score on a scale | Standard Deviation 27.7 |
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | 8 weeks | 70.1 score on a scale | Standard Deviation 28.4 |
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | 12 weeks | 66.8 score on a scale | Standard Deviation 24.8 |
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | 26 weeks | 68.8 score on a scale | Standard Deviation 25.3 |
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | 52 weeks | 68.4 score on a scale | Standard Deviation 25.1 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | 26 weeks | 67.1 score on a scale | Standard Deviation 27.1 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | baseline | 40.4 score on a scale | Standard Deviation 21.9 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | 12 weeks | 63.6 score on a scale | Standard Deviation 26.8 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | 4 weeks | 71.9 score on a scale | Standard Deviation 25.7 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | 52 weeks | 73.1 score on a scale | Standard Deviation 29 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | 8 weeks | 67.4 score on a scale | Standard Deviation 26.8 |
Primary
Foot Health Status Questioner (FHSQ) PAIN
Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | 4 weeks | 73.4 score on a scale | Standard Deviation 27.7 |
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | 12 weeks | 66.8 score on a scale | Standard Deviation 24.8 |
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | baseline | 38.8 score on a scale | Standard Deviation 18.8 |
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | 26 weeks | 68.8 score on a scale | Standard Deviation 25.3 |
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | 8 weeks | 70.1 score on a scale | Standard Deviation 28.4 |
| Dry Needling (DN) Arm | Foot Health Status Questioner (FHSQ) PAIN | 52 weeks | 68.4 score on a scale | Standard Deviation 25.1 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | 8 weeks | 67.4 score on a scale | Standard Deviation 26.8 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | baseline | 40.4 score on a scale | Standard Deviation 21.9 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | 4 weeks | 71.9 score on a scale | Standard Deviation 25.7 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | 52 weeks | 73.1 score on a scale | Standard Deviation 29 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | 12 weeks | 63.6 score on a scale | Standard Deviation 26.8 |
| Percutaneous Needle Electrolysis (PNE) Arm | Foot Health Status Questioner (FHSQ) PAIN | 26 weeks | 67.1 score on a scale | Standard Deviation 27.1 |
Secondary
The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dry Needling (DN) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | 4 weeks | 0.78 units on a scale | Standard Deviation 0.22 |
| Dry Needling (DN) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | 12 weeks | 0.64 units on a scale | Standard Deviation 0.3 |
| Dry Needling (DN) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | 26 weeks | 0.65 units on a scale | Standard Deviation 0.29 |
| Dry Needling (DN) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | 8 weeks | 0.72 units on a scale | Standard Deviation 0.23 |
| Dry Needling (DN) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | 52 weeks | 0.66 units on a scale | Standard Deviation 0.27 |
| Dry Needling (DN) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | baseline | 0.63 units on a scale | Standard Deviation 0.23 |
| Percutaneous Needle Electrolysis (PNE) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | 52 weeks | 0.77 units on a scale | Standard Deviation 0.25 |
| Percutaneous Needle Electrolysis (PNE) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | 12 weeks | 0.70 units on a scale | Standard Deviation 0.27 |
| Percutaneous Needle Electrolysis (PNE) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | baseline | 0.67 units on a scale | Standard Deviation 0.22 |
| Percutaneous Needle Electrolysis (PNE) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | 4 weeks | 0.76 units on a scale | Standard Deviation 0.24 |
| Percutaneous Needle Electrolysis (PNE) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | 8 weeks | 0.74 units on a scale | Standard Deviation 0.23 |
| Percutaneous Needle Electrolysis (PNE) Arm | The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) | 26 weeks | 0.73 units on a scale | Standard Deviation 0.27 |
Secondary
VAS Maximum
Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable
Time frame: 1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dry Needling (DN) Arm | VAS Maximum | baseline 1st session | 7.6 units on a scale | Standard Deviation 2 |
| Dry Needling (DN) Arm | VAS Maximum | 2nd session | 6.2 units on a scale | Standard Deviation 2.3 |
| Dry Needling (DN) Arm | VAS Maximum | 3rd session | 5.4 units on a scale | Standard Deviation 2.6 |
| Dry Needling (DN) Arm | VAS Maximum | 4th session | 4.9 units on a scale | Standard Deviation 2.9 |
| Percutaneous Needle Electrolysis (PNE) Arm | VAS Maximum | 4th session | 4.5 units on a scale | Standard Deviation 3 |
| Percutaneous Needle Electrolysis (PNE) Arm | VAS Maximum | baseline 1st session | 7.5 units on a scale | Standard Deviation 2.3 |
| Percutaneous Needle Electrolysis (PNE) Arm | VAS Maximum | 3rd session | 5.3 units on a scale | Standard Deviation 3.1 |
| Percutaneous Needle Electrolysis (PNE) Arm | VAS Maximum | 2nd session | 5.5 units on a scale | Standard Deviation 2.9 |