Myofascial Pain Syndrome of Neck Clinical Trial
Official title:
The Effectiveness of Radial Shockwave Therapy on Myofascial Pain Syndrome: A Mixed Method Study That Combines a Randomised Control Trial and Semi-Structured Interview.
NCT number | NCT05381987 |
Other study ID # | RAC# 2221047 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 21, 2022 |
Est. completion date | March 2023 |
Verified date | May 2022 |
Source | King Faisal Specialist Hospital & Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction: Myofascial pain syndrome (MPS) is a common, costly and often persistent musculoskeletal problem. Radial shockwave (RSW) is one of the most common treatment for MFS. However, a recent systematic review found very low-level evidence to support its short-term benefit, due to poor methodological qualities. The authors therefore recommended further large scale, good quality placebo-controlled trials (RCT) in this area. Further still, previous studies have not considered the experiences of patient regarding this intervention. Study Objectives: To determine the effectiveness of RSW compared to placebo for the treatment of patients with MPS in neck and upper back, and to establish the experiences of patients receiving the treatment. Research Questions: Is RSW therapy more effective at improving MPS compared to a placebo? What are the experiences of patients with MPS receiving this treatment? Methods: A pragmatic double blind RCT to investigate the effectiveness of RSW on patients with MPS and a semi-structured-interview to investigate the patients' experience of receiving the treatment. Sample: 120 potential participants with MPS for the RCT and 20 participants for the semi-structured qualitative interview. Interventions: The Intervention group will receive a total of 6 sessions of RSW following manufacturer's parameters: 1.5 bar, pulses 2000, frequency 15 Hz (Time 3 minutes). The Control group will receive an identical treatment except that the they will receive a no energy shock of 0.3 bar, frequency 15 and no pulses. Outcome measures: Improvements in the patient's numeric pain scale (NPS), neck disability index (NDI), pressure pain threshold (PPT) and SF-12 questionnaires at 4, 8 and 12 weeks' follow-up between the two groups. Significance of the Study's Outcome: The expectation is that this study will add to the body of knowledge required to help patients, healthcare practitioners, policy makers and researchers make effective treatment choices on RSW in the management MFS.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | March 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients aged 19 and above - Neck and or upper back pain localised the lateral or posterior neck and or upper back - Palpable tenderness in the lateral or posterior neck and or upper back - Trigger points in lateral or posterior neck and or upper back - Able to give informed consent Exclusion Criteria: - Patients below 19 years of age - History of: - Malignancy - Lung tissue - Haemophiliacs or patients on anticoagulant therapy - Visible tissue damage (skin petechiae & microvasculature disruption) - Metal implants - implanted cardiac stents & heart valves - Infection - Rheumatic, respiratory, cardiovascular diseases - Psychopathy - Disorders of the vestibular and visual systems - neck or shoulder surgery within a year, - Recent history steroid injections to myofascial trigger point - Pregnancy - Diagnosed as: • Fibromyalgia, cervical radiculopathy or myelopathy - Inability and unwillingness to continue study - Failure to consent |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Physical Rehabilitation Department, King Faisal Specialist Hospital & Research Centre | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Faisal Specialist Hospital & Research Center |
Saudi Arabia,
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* Note: There are 44 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric pain rating scale (NPRS) | NPRS is a single 11-point numeric scale (with 0 as "no pain" and 10 as the "worse imaginable pain") to measure pain intensity in adults (Hawker 2011). It allows patients to measure their level of pain accordingly using a whole number (0-10 integers) that corresponds to their pain intensity (Rodriguez, 2001). The scale is considered reliable (accurate and consistent), responsive (ability to detect clinically significant changes) and valid (actually measures what it sets out to) (Hawker, 2011). Accordingly, a pain reduction of 2 points, or 30%, on the NPRS scores is defined as Minimal Clinically Important Difference (MCID) [Childs et al, 2005; Farrar et al, 2001]. The NPS is relatively easy to comprehend, and to apply, especially by patients with musculoskeletal disorders (Hawker, 2011). | 12 weeks | |
Primary | Neck Disability Index (NDI) | It is the most commonly used self-rated disability score for assessing patients with neck pain Vernon & Mior (1991). It consists of ten domains: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All sections are then totalled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst. The score can also be reported as a percentage (0-100%). The Minimum Detectable Change (90% confidence) is 5 points or 10% points Vernon & Mior (1991), and the MCID is in the range of 3.5-5.0 points (Pool et al, 2007). | 12 weeks | |
Primary | Pressure pain threshold (PPT) | It will be measured using a digital algometer and pain score measurement will be performed with digital palpation. The algometer circular flat tip with 1.0 cm2 surface will be slowly pushed vertically to the skin over the trigger points until the participants interprets the compression on skin as pain sensation. The exerted pressure will be enlarged at a rate of 1 kg/cm2. Participants will be requested to inform the treating physiotherapist by saying "yes" when the pain is perceived. The measurements will be taken three times with 40 seconds intervals, and the mean average value will be taken (Fischer, 1998). A mean difference of 0.94 kg/cm2 in PPT was defined as MCID (Asiri et al, 2020). | 12 weeks | |
Primary | SF12 - Quality of life (QoL) | Quality of life status will be evaluated using the short form (SF12), which is a shorter version of SF-36 questionnaire. The health survey (SF-12) questionnaire, consists of 12 items regarding the quality of life with respect to the physical and emotional aspects. Likert scales and yes/no options were used to assess function and wellbeing on this 12-item questionnaire. To score the SF-12, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status. It is one of the most widely used patient report outcome with well documented high validity, reliability, and responsiveness rate among many groups varying by age, sex, socio-economic status, geographical region, and clinical conditions (Ware et al, 2000). | 12 weeks |
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