Effects of Fascia Therapy Versus Facial Manipulation on Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
DBM fasciatherapy+ conventional physical therapy
fascial manipulation+ conventional physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Fascia Therapy, Facial Manipulation
Eligibility Criteria
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
Sites / Locations
- Riphah Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fascia Therapy
Facial Manipulation
Arm Description
Group A will receive Fascia therapy
Group B will receive Facial manipulation
Outcomes
Primary Outcome Measures
1. NPRS (numeric pain rating scale)
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.
2. Goniometer
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.
NDI
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05272111
First Posted
February 20, 2022
Last Updated
October 17, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05272111
Brief Title
Effects of Fascia Therapy Versus Facial Manipulation on Neck Pain
Official Title
Effects of Fasciatherapy Versus Facial Manipulation on Pain, Range of Motion and Function in Patients With Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Fascia Therapy, Facial Manipulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fascia Therapy
Arm Type
Experimental
Arm Description
Group A will receive Fascia therapy
Arm Title
Facial Manipulation
Arm Type
Experimental
Arm Description
Group B will receive Facial manipulation
Intervention Type
Other
Intervention Name(s)
DBM fasciatherapy+ conventional physical therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
fascial manipulation+ conventional physical therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
1. NPRS (numeric pain rating scale)
Description
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.
Time Frame
6th Week
Title
2. Goniometer
Description
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.
Time Frame
6th Week
Title
NDI
Description
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.
Time Frame
6th Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil ur Rehman
Organizational Affiliation
Riphah International University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Syeda Aiman Batool
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20466711
Citation
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.
Results Reference
background
PubMed Identifier
19524848
Citation
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.
Results Reference
background
PubMed Identifier
26834998
Citation
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.
Results Reference
background
PubMed Identifier
32317109
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
29856244
Citation
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.
Results Reference
background
PubMed Identifier
19329049
Citation
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.
Results Reference
background
Citation
Courraud C, Bertrand I, Dupuis C. Assessment of the effects of DBM fasciatherapy on fascial system with elastography.
Results Reference
background
PubMed Identifier
21589701
Citation
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.
Results Reference
background
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Effects of Fascia Therapy Versus Facial Manipulation on Neck Pain
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