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Effects of Holistic Spinal Fascial Mobilization in Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Fascial mobilization group
Conventional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Fascia, Range of motion, Mobilization

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bhawal Victoria Hospital, Bhawalpur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A

Group B

Arm Description

baseline physical therapy treatment along with facial mobilization

baseline (Conventional) physical therapy treatment

Outcomes

Primary Outcome Measures

NPRS
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
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 5.
Goniometric measurement of Neck ROM
A goniometer is an instrument which measures the available range of motion at a joint.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
January 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05392465
Brief Title
Effects of Holistic Spinal Fascial Mobilization in Neck Pain
Official Title
Effects of Holistic Spinal Fascial Mobilization on Pain, Range of Motion and Function in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Fascia, Range of motion, Mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
baseline physical therapy treatment along with facial mobilization
Arm Title
Group B
Arm Type
Other
Arm Description
baseline (Conventional) physical therapy treatment
Intervention Type
Other
Intervention Name(s)
Fascial mobilization group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
NPRS
Description
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
Time Frame
3rd day
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 5.
Time Frame
3rd day
Title
Goniometric measurement of Neck ROM
Description
A goniometer is an instrument which measures the available range of motion at a joint.
Time Frame
3rd day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil-ur Rehman
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bhawal Victoria Hospital, Bhawalpur
City
Bahawalpur
State/Province
Punjab
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
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PubMed Identifier
16323384
Citation
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.
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Citation
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.
Results Reference
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PubMed Identifier
19166469
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
28956477
Citation
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.
Results Reference
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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
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Citation
Courraud C, Bertrand I, Dupuis C. Assessment of the effects of DBM fasciatherapy on fascial system with elastography.
Results Reference
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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
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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
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Effects of Holistic Spinal Fascial Mobilization in Neck Pain

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