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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06459518
Other study ID # REC/RCR&AHS/23/01106
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 15, 2024
Est. completion date September 26, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact Imran Amjad, Phd
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mechanical neck pain, also known as non-specific neck pain, is a prevalent ailment that results from problems with spine and surrounding tissue function. Trauma, degenerative changes, strained muscles, and bad posture are among the causes. The range of symptoms includes headaches, stiffness, and mild to severe pain. The goal of treatment is to strengthen the muscles and improve posture. The diagnosis is clinical. The Bowen Technique is a type of gentle bodywork therapy that promotes relaxation and overall rebalancing by using specific movements to activate the autonomic nerve system. It is sought for the improvement of general well-being, pain alleviation, and stress reduction. Patients undergoing manual treatment will be asked to actively contract their muscles against regulated resistance using the Muscle Energy Technique (MET). It addresses problems including joint limitations and attempts to return muscles and joints to their normal functions.


Description:

The research, will last for ten months at the Limit Institute of Health Sciences in Sahiwal, is a randomized controlled trial. With 10 participants in each group using a non-probability convenient sampling procedure, the sample size includes 10% attrition. Computer users between the ages of 18 and 35 who work five to seven hours a day meet the inclusion criteria, but recent musculoskeletal injuries and a history of head or spine trauma are the exclusion criteria. One instrument used to collect data is the Neck Disability Index (NDI). There are two established study groups: Group B will receive Muscle Energy Technique (MET) and traditional physiotherapy, while Group A will receive Bowen therapy and conventional physiotherapy. Blinding will be used, and the study will adhere to a recruitment, enrollment, and randomization procedure. SPSS version 23 will be used to analyze the data, and descriptive statistics, change over temporal analysis as well as tests of group comparison. The purpose of the study is to evaluate how the interventions affect people who use computers for extended periods in terms of their functional results and mechanical neck discomfort.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date September 26, 2024
Est. primary completion date August 25, 2024
Accepts healthy volunteers No
Gender All
Age group 15 Years to 35 Years
Eligibility Inclusion Criteria: - Computer users who work 5-7 hours daily. - Age between 18 to 35 will be included. - Both genders Exclusion Criteria: - Any recent musculoskeletal injury of upper limb or spine. - History of any trauma of spine or head

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bowen Therapy along with conventional therapy
Bowen Technique Group Assignment: Participants will be assigned to undergo targeted Bowen Technique therapy sessions. Session Details: The therapy sessions will include: Gentle, rolling-type maneuvers Specific placements of fingers and thumbs Focus on muscles, tendons, and ligaments associated with neck pain Therapeutic Pauses: There will be intentional pauses between sets of moves to allow the body time to respond to the therapeutic stimulation. Conventional Therapy: Hot pack, TENS, Passive Stretching 2 times a week for 4 weeks
Muscle Energy Technique with Conventional Therapy
MET Session Structure: Participants will engage in Muscle Energy Technique (MET) sessions that focus on: Isometric muscle contractions, where muscles are contracted without changing length. Therapist-guided, controlled contractions against specific resistance. Relaxation Periods: Each contraction session will be followed by a period of relaxation to allow muscles to recover and respond to the therapy. conventional therapy: Hot pack, TENS, Passive Stretching 2times a week for 4 weeks.

Locations

Country Name City State
Pakistan Maryam Polyclinic Sahiwal Sahiwal Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Al-Khazali HM, Kroll LS, Ashina H, Melo-Carrillo A, Burstein R, Amin FM, Ashina S. Neck pain and headache: Pathophysiology, treatments and future directions. Musculoskelet Sci Pract. 2023 Aug;66:102804. doi: 10.1016/j.msksp.2023.102804. Epub 2023 Jun 16. — View Citation

Bonilla-Barba L, Florencio LL, Rodriguez-Jimenez J, Falla D, Fernandez-de-Las-Penas C, Ortega-Santiago R. Women with mechanical neck pain exhibit increased activation of their superficial neck extensors when performing the cranio-cervical flexion test. Musculoskelet Sci Pract. 2020 Oct;49:102222. doi: 10.1016/j.msksp.2020.102222. Epub 2020 Jul 11. — View Citation

Joshi S, Balthillaya G, Neelapala YVR. Thoracic Posture and Mobility in Mechanical Neck Pain Population: A Review of the Literature. Asian Spine J. 2019 Jun 3;13(5):849-860. doi: 10.31616/asj.2018.0302. Print 2019 Oct. — View Citation

Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019. — View Citation

Peng B, Yang L, Li Y, Liu T, Liu Y. Cervical Proprioception Impairment in Neck Pain-Pathophysiology, Clinical Evaluation, and Management: A Narrative Review. Pain Ther. 2021 Jun;10(1):143-164. doi: 10.1007/s40122-020-00230-z. Epub 2021 Jan 12. — View Citation

Verhagen AP. Physiotherapy management of neck pain. J Physiother. 2021 Jan;67(1):5-11. doi: 10.1016/j.jphys.2020.12.005. Epub 2020 Dec 24. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain level The Numeric Pain Rating Scale (NPRS) is a straightforward tool used to measure pain intensity in adults, including those suffering from chronic pain associated with rheumatic conditions. It features an 11-point scale, where '0' indicates no pain and '10' signifies the most extreme pain possible, described as "pain as bad as you can imagine" or "the worst pain imaginable." 4th week
Primary Functional Disability A self-reported questionnaire called the Neck Disability Index (NDI) is used to gauge how neck pain affects a person's ability to function and go about their everyday life. It is divided into eleven sections that address different tasks such as sleeping, work, reading, lifting, and personal care. In each category, respondents rate the level of difficulty they encounter; scores are added together to produce a percentage that indicates the degree of disability. When conducting clinical assessments, the NDI is a useful instrument that helps medical practitioners determine the degree of functional limits and provide personalized interventions for patients with neck discomfort. 4th week
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