- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392465
Effects of Holistic Spinal Fascial Mobilization in Neck Pain
January 31, 2023 updated by: Riphah International University
Effects of Holistic Spinal Fascial Mobilization on Pain, Range of Motion and Function in Patients With Chronic Neck Pain
This study aims to determine the effects of holistic spinal fascial mobilization on pain, range of motion and function in patients with chronic neck pain so that we can have the best treatment option for patients with chronic neck pain, the duration will be 10 months, purposive sampling will be done, subject following eligibility criteria from bahawal Victoria hospital Bahawalpur, were allocated in two groups, a baseline assessment was done, Group A participants were given conventional treatment along with fascial mobilization, Group B participants were given conventional treatment, Numeric pain rating scale(NPRS), Neck Disability Index(NDI) and Goniometry for a range of motion,3 sessions per week were given, data was analyzed by using SPSS version 25.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chronic neck pain is one of the most common musculoskeletal disorders among the general population.
Like a muscular spasm of the neck that can cause neck pain, fascial adhesions are also a common cause of neck pain.
Fascia is a form of connective tissue that is made up of collagen, surrounds the body parts, and also resists tissue tensile load.
There is huge literature regarding the management of neck pain and yet after decades of research, there are gaps in treatment options.
In the modern age of health care, it is a common goal of every health care to make patients self-sufficient as early as possible.
The self-care models have tremendous advantages.
The current study aims to determine the effects of holistic spinal fascial mobilization on pain, range of motion, and function in patients with chronic neck pain.
All treatment methods were employed to see if they improve the ranges accompanying pain and disability.
Study Type
Interventional
Enrollment (Actual)
38
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
-
Bahawalpur, Punjab, Pakistan
- Bhawal Victoria Hospital, Bhawalpur
-
-
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
25 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Both genders.
- Age 25-60 years.
- NPRS >4
- Subjects diagnosed with chronic neck pain with minimum 3 months of chronicity
- Subjects without any other pathology affecting the neck and upper limb.
Exclusion Criteria:
- Subjects with a history of Vertebro-Basilar artery insufficiency
- Any bony, soft tissue, systemic disease, fever, malnutrition or tumor.
- Surgery
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Group A
baseline physical therapy treatment along with facial mobilization
|
Fascial mobilization+ conventional treatment (3 sessions per week).
MFR is thought to work directly on restricted fascia; practitioners use knuckles or elbow to slowly sink into the fascia, and the pressure applied to contact the restricted fascia, apply tension, or stretch the fascia.
MFR involves application of gentle stretch the pressure applied is a few grams of force, and the hands tend to follow the direction of fascial restriction, hold the stretch, and allow the fascia to release itself + hot pack (10 min) + neck isometrics (neck flexion, extension, side bending) + neck stretches (neck flexors, extensors, side benders and rotation).A total of 40-45 min session three times a week on alternate days for three weeks.
|
|
OTHER: Group B
baseline (Conventional) physical therapy treatment
|
Conventional Therapy (3 sessions per week).
In this treatment group conventional treatment for chronic neck pain will be given which includes hot pack, Neck Isometrics and Neck Stretches.
Hot pack (10 min) + neck isometrics (neck flexion, extension, side bending) + neck stretches (neck flexors, extensors, side benders and rotators).A total of 40-45 min session three times a week on alternate days for three weeks On eligible participants baseline assessment was done,3 session were given per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS
Time Frame: 3rd day
|
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10.
Where 0 indicate no pain and 10 indicate severe pain
|
3rd day
|
|
NDI
Time Frame: 3rd day
|
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 5.
|
3rd day
|
|
Goniometric measurement of Neck ROM
Time Frame: 3rd day
|
A goniometer is an instrument which measures the available range of motion at a joint.
|
3rd day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- Chiu TT, Hui-Chan CW, Chein G. A randomized clinical trial of TENS and exercise for patients with chronic neck pain. Clin Rehabil. 2005 Dec;19(8):850-60. doi: 10.1191/0269215505cr920oa.
- Bakry HA. The effect of poor posture on the cervical range of motion in young subjects. Egyptian Journal of Physical Therapy. 2021;5(1):5-12.
- Benjamin M. The fascia of the limbs and back--a review. J Anat. 2009 Jan;214(1):1-18. doi: 10.1111/j.1469-7580.2008.01011.x.
- Hrkal P. Fascia: The Tensional Network of the Human Body: The science and clinical applications in manual and movement therapy. Journal of the Canadian Chiropractic Association. 2015;59(4):417-8.
- Laimi K, Makila A, Barlund E, Katajapuu N, Oksanen A, Seikkula V, Karppinen J, Saltychev M. Effectiveness of myofascial release in treatment of chronic musculoskeletal pain: a systematic review. Clin Rehabil. 2018 Apr;32(4):440-450. doi: 10.1177/0269215517732820. Epub 2017 Sep 28.
- 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.
- Courraud C, Bertrand I, Dupuis C. Assessment of the effects of DBM fasciatherapy on fascial system with elastography.
- 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.
- 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)
May 30, 2022
Primary Completion (ACTUAL)
December 30, 2022
Study Completion (ACTUAL)
January 30, 2023
Study Registration Dates
First Submitted
May 23, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (ACTUAL)
May 26, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 1, 2023
Last Update Submitted That Met QC Criteria
January 31, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0144 Nimra
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.
Clinical Trials on Neck Pain
-
Hochschule OsnabruckNot yet recruitingNeck Pain | Chronic Neck Pain | Neck Disability | Neck Pain Musculoskeletal | Neck Disease
-
Istanbul University - CerrahpasaRecruitingNonspecific Neck Pain | Neck Pain MusculoskeletalTurkey (Türkiye)
-
Universitat Internacional de CatalunyaNot yet recruitingChronic Neck Pain | Non-specific Neck PainSpain
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
Benha UniversityCompletedNeck Pain | Mechanical Neck Pain | Pain Threshold | Cervical Pain, Posterior | Neck Pain Musculoskeletal | Extracorporeal Shock Wave TherapyEgypt
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
University of LahoreCompletedNeck Pain | Mechanical Neck Pain | Mobilization | Neck Pain Musculoskeletal | Proprioceptive Neuromuscular FacilitationPakistan
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Hacettepe UniversityNot yet recruitingChronic Neck PainTurkey (Türkiye)
-
Istanbul Rumeli UniversityEnrolling by invitationNeck Pain | Neck Pain MusculoskeletalTurkey (Türkiye)
Clinical Trials on Fascial mobilization group
-
Karabuk UniversityCompleted
-
Rocky Mountain University of Health ProfessionsFranklin Pierce University; Section on Women's Health American Physical Therapy...UnknownCicatrix | Cesarean Section | Tissue AdhesionsUnited States
-
Sheba Medical CenterCompleted
-
Hasan Kalyoncu UniversityCompletedPost Partum | Carpal Tunnel Syndrome (CTS) | Fascial MobilizationTurkey (Türkiye)
-
Mardin Artuklu UniversityEnrolling by invitationObstructive Sleep Apnea SyndromesTurkey (Türkiye)
-
Riphah International UniversityCompletedAdhesive CapsulitisPakistan
-
Hasan Kalyoncu UniversityNot yet recruitingExercise | Hand Flexor Tendon | Facial MobilizationTurkey (Türkiye)
-
Hacettepe UniversityUnknown
-
Karabuk UniversityRecruiting
-
Real Fundación Victoria EugeniaCompleted