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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05272111
Other study ID # REC/RCRS/22/0102 Aiman
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2022
Est. completion date August 30, 2022

Study information

Verified date October 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date August 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
DBM fasciatherapy+ conventional physical 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
fascial manipulation+ conventional physical therapy
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

Locations

Country Name City State
Pakistan Riphah Rehabilitation Center Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

Branchini M, Lopopolo F, Andreoli E, Loreti I, Marchand AM, Stecco A. Fascial Manipulation® for chronic aspecific low back pain: a single blinded randomized controlled trial. Version 2. F1000Res. 2015 Nov 3 [revised 2016 Jan 1];4:1208. doi: 10.12688/f1000research.6890.2. eCollection 2015. — View Citation

Courraud C, Bertrand I, Dupuis C. Assessment of the effects of DBM fasciatherapy on fascial system with elastography.

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. — View 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.

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. Review. — View Citation

Queré N, Noël 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. — View Citation

Rodríguez-Huguet M, Rodríguez-Almagro D, Rodríguez-Huguet P, Martín-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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6th Week
Primary 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. 6th Week
Primary 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. 6th Week
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