- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05272111
Effects of Fascia Therapy Versus Facial Manipulation on Neck Pain
October 17, 2022 updated by: Riphah International University
Effects of Fasciatherapy Versus Facial Manipulation on Pain, Range of Motion and Function in Patients With Chronic Neck Pain
This study a randomized clinical trial to determine the effects of fasiatherapy versus facial manipulation on pain, range of motion and function in patients with chronic neck pain.
A sample of 52 patients will be taken and divided into two groups each with 26 patients.
Group A will receive DBM fasciatherapy along with conventional physical therapy while group B will receive fascial manipulation along with the conventional physical therapy protocol.
The conventional physical therapy protocol will include hot pack, neck isometrics and stretches.
The session will be around 45 to 60 min on each patient with three session per week on alternate days.
A total of three-week treatment regime will be given to the patients and assessment of patient's pain, range of motion and function with NPRS (numeric pain rating scale), goniometry and NDI (neck disability index) will be done at the baseline, after the completion of treatment at three weeks and after 6 weeks to observe the long-term effects.
The data will be analyzed using SPSS.
Study Overview
Status
Completed
Conditions
Detailed Description
Chronic neck pain is one of the most common musculoskeletal disorder among general population.
Like muscular spasm of neck that can cause neck pain, fascial adhesions are also the common cause of neck pain.
Fascia is a form of connective tissue that is made up of collagen, surrounds the body parts and also resist tissue tensile load.
Fascial injury and adhesions are common and can lead to pain, restricted motion and swelling.
The treatment of the fascial injury is necessary to relieve those symptoms.
There are many treatments for the chronic neck pain and this study focuses on two new treatment techniques for the fascial pain.
The first is the Dannis Bois method fasciatherpy which is a manual approach that focuses on the structural segmentation of fascia and involves the application of gentle pressure while stretching the body's connective tissues.
The other treatment technique is the fascial manipulation method that involves the treatment which is directed to specific fascial adhesions.
The current study is novel in a way that there is limited literature about DBM fasciatherapy versus fascial manipulation on chronic neck pain.
Both methods were employed to see if they improve ranges along with accompanying pain and disability.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah Rehabilitation Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Both genders
- Age 18-40 years
- Chronicity of pain - 6 months minimum
Exclusion Criteria:
- Post-op patient
- Any bony, soft tissue or systemic disease
- Pregnant females
- Radiculopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fascia Therapy
Group A will receive Fascia therapy
|
DBM fasciatherapy (3 sessions per day).
It soft, deep and non-manipulative form of treatment that involves the application of gentle pressure while stretching the body's connective tissue.
A specialized form of touch, somatic sense, and specific body movement protocols are the three steps involved in the fasciatherapy.
+ hot pack (10 min) + neck isometrics (neck flexion, extension, side bending) + neck stretches (neck flexors, extensors, side benders and rotation).
A total of 45 min session three times a week on alternate days for three weeks
|
Experimental: Facial Manipulation
Group B will receive Facial manipulation
|
Fascial manipulation (3 sessions per day).
This technique involves the identification of specific, localized areas of the fascia with limited movements.
Once it is identified, then a specific point on the fascia is targeted and through the appropriate manipulation of this precise part of the fascia, movement can be restored.
+ hot pack (10 min) + neck isometrics (neck flexion, extension, side bending) + neck stretches (neck flexors, extensors, side benders and rotation).
A total of 45 min session three times a week on alternate days for three weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1. NPRS (numeric pain rating scale)
Time Frame: 6th Week
|
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain.
|
6th Week
|
2. Goniometer
Time Frame: 6th Week
|
The science of measuring the joint ranges in each plane of the joint is called goniometry.
Goniometer is a device that measures an angle or permits the rotation of an object to a definite position.
Neck flexion, extension, side bending and rotation will be assessed through it.
|
6th Week
|
NDI
Time Frame: 6th Week
|
The NDI has become a standard instrument for measuring self-rated disability due to neck pain.
Each of the 10 items scores from 0 to 5. The maximum score is 50.
|
6th Week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Syed Shakil ur Rehman, Riphah International University
- Principal Investigator: Syeda Aiman Batool, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.
- Branchini M, Lopopolo F, Andreoli E, Loreti I, Marchand AM, Stecco A. Fascial Manipulation(R) for chronic aspecific low back pain: a single blinded randomized controlled trial. F1000Res. 2015 Nov 3;4:1208. doi: 10.12688/f1000research.6890.2. eCollection 2015.
- McLean SM, May S, Klaber-Moffett J, Sharp DM, Gardiner E. Risk factors for the onset of non-specific neck pain: a systematic review. J Epidemiol Community Health. 2010 Jul;64(7):565-72. doi: 10.1136/jech.2009.090720. Epub 2010 May 12.
- Quere N, Noel E, Lieutaud A, d'Alessio P. Fasciatherapy combined with pulsology touch induces changes in blood turbulence potentially beneficial for vascular endothelium. J Bodyw Mov Ther. 2009 Jul;13(3):239-45. doi: 10.1016/j.jbmt.2008.06.012. Epub 2008 Aug 12.
- Rodriguez-Huguet M, Rodriguez-Almagro D, Rodriguez-Huguet P, Martin-Valero R, Lomas-Vega R. Treatment of Neck Pain With Myofascial Therapies: A Single Blind Randomized Controlled Trial. J Manipulative Physiol Ther. 2020 Feb;43(2):160-170. doi: 10.1016/j.jmpt.2019.12.001. Epub 2020 Apr 18.
- Mawdsley RH, Moran KA, Conniff LA. Reliability of two commonly used pain scales with elderly patients. Journal of Geriatric Physical Therapy. 2002;25(3):16.
- Day JA, Stecco C, Stecco A. Application of Fascial Manipulation technique in chronic shoulder pain--anatomical basis and clinical implications. J Bodyw Mov Ther. 2009 Apr;13(2):128-35. doi: 10.1016/j.jbmt.2008.04.044. Epub 2008 Jun 24.
- Courraud C, Bertrand I, Dupuis C. Assessment of the effects of DBM fasciatherapy on fascial system with elastography.
- Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2022
Primary Completion (Actual)
July 30, 2022
Study Completion (Actual)
August 30, 2022
Study Registration Dates
First Submitted
February 20, 2022
First Submitted That Met QC Criteria
March 8, 2022
First Posted (Actual)
March 9, 2022
Study Record Updates
Last Update Posted (Actual)
October 19, 2022
Last Update Submitted That Met QC Criteria
October 17, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCRS/22/0102 Aiman
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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