Comparing Efficacy of Dry Needling Combined with Passive Stretching and Muscle Energy Technique on Myofascial Trigger Points

Not Applicable

Recruiting

• Conditions: Neck Pain

• Registration Number: NCT06780904
• Lead Sponsor: University of Peradeniya

Brief Summary

The goal of this clinical trial is to assess and compare the efficacy of dry needling (minimally invasive treatment by using a tiny needle) combined with two types of stretching techniques in patients with neck pain for more than 3 months. The main questions it aims to answer are:

Which combination of treatment will 1.give faster relief of pain? 2.improve neck range of motion? and 3.improve disability level of a person with neck pain.

Participants who are interested will be selected according to eligibility criteria. Participants will be divided into two groups. Initially researcher will assess and interview the participants. Two groups will receive two different combinations of interventions. Pre and post measurements will be obtained and then treatment efficacy will be assessed.

Detailed Description

46 participants who are interested in this study will be recruited by using convenient sampling method and according to the inclusion and exclusion criteria. Participants then will be divided into two groups by using opaque sealed envelop method.

Initially participants will be interviewed an outcome measures will be taken. As outcome measures Pain will be assessed by using Visual Analogue Scale (VAS), Disability level will be assessed by using Neck Disability Index(NDI), and Neck Range of Motion will be measured by using Universal Goniometer. Participants will receive interventions, two times per week for two weeks. Soon after the last intervention, same outcome measures will be taken again.

Statistical Package for Social Science (SPSS) version 27 (IBM, USA) for Windows will be used for data analysis. The data will be examined using exploratory statistics, and the distributions will be inspected for violations of normality using graphical methods and the Shapiro-Wilk test. Descriptive statistics of the demographic variables and test measurements will be calculated. Based on the satisfaction or violation of normal distribution assumptions, pain intensity (VAS), neck ROMs, pain intensity, and Neck Disability Index (NDI) will be analyzed using parametric or non-parametric tests. Baseline data for pain intensity, neck ROMs and NDI and pain intensity will be compared between the two intervention groups using paired t-test or Wilcoxon signed-rank test. The difference-in changes in each outcome relative to the baseline between intervention groups will be compared using paired t-test or Wilcoxon signed-rank test

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Presence of neck pain for at least 3 months or more
• Presence of trigger points in the upper trapezius muscle, either unilaterally or bilaterally
• Age between 18 and 60 years

Exclusion Criteria

• Having an ongoing infection or fever
• Presence of shoulder pathology, such as tendinopathy, impingement syndrome, capsulitis, or bursitis
• History of direct trauma to the shoulder or neck
• Immunosuppressed individuals (e.g., those with cancer)
• Pregnant or recently delivered
• Diagnosis of fibromyalgia
• History of previous neck or shoulder surgery
• Previous local steroid injection or acupuncture
• Any abnormality that restricts cervical range of motion (e.g., degenerative changes, cervical spine spondylolisthesis, disc protrusion, extrusion, or sequestration observed in MRI)
• Uncontrolled diabetes mellitus
• Needle phobia
• Metal allergies
• Cervical instability
• Presence of local skin lesions or infections
• Significant cognitive impairment or uncooperative behavior
• Participants who have previously undergone any form of physiotherapy intervention for the treatment of neck pain or related conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neck pain	2 weeks	Visual Analog Scale (VAS) 0: Represents the minimum value, such as "no pain" or "no discomfort." 100: Represents the maximum value, such as "worst pain imaginable" or "extreme discomfort.

Secondary Outcome Measures

Name	Time	Method
Neck Range of Motion	2 weeks	Neck flexion, Extension, Side flexion to affected side, Side flexion to unaffected side, Rotation to affected side and Rotation to unaffected side
Neck disability level	2 weeks	Neck Disability Index Structure: Contains 10 items, each scored on a 0-5 scale Scoring: Total score ranges from 0 to 50, Higher scores indicate greater disability.

Trial Locations

Locations (1)

National Hospital Kandy; 🇱🇰 Kandy, Central, Sri Lanka