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

NCT ID: NCT06780904

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-03-01

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

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group 1

Dry needling + Passive stretching

Group Type: ACTIVE_COMPARATOR

Dry Needling

Intervention Type: PROCEDURE

Treatment protocol:

1. Dry needling: Prone position, identify trigger points in upper trapezius, use Hong technique with 50mm/0.25 gauge needle, eliciting local twitch response.

2. Passive stretching: Supine position, cervical spine stretched just short of restriction, hold for 30s with 20s rest, repeat 3 times.

3. Muscle Energy Technique: Supine position, identify restriction barrier, move spine away from barrier, instruct patient to isometrically contract opposing movement (25% strength), hold for 7-10s, then stretch towards new barrier for 30s, repeat 3 times.

Treatment group 2

Dry needling + Muscle Energy technique

Group Type: OTHER

Dry Needling

Intervention Type: PROCEDURE

Treatment protocol:

1. Dry needling: Prone position, identify trigger points in upper trapezius, use Hong technique with 50mm/0.25 gauge needle, eliciting local twitch response.

2. Passive stretching: Supine position, cervical spine stretched just short of restriction, hold for 30s with 20s rest, repeat 3 times.

3. Muscle Energy Technique: Supine position, identify restriction barrier, move spine away from barrier, instruct patient to isometrically contract opposing movement (25% strength), hold for 7-10s, then stretch towards new barrier for 30s, repeat 3 times.

Interventions

Dry Needling

Treatment protocol:

1. Dry needling: Prone position, identify trigger points in upper trapezius, use Hong technique with 50mm/0.25 gauge needle, eliciting local twitch response.

2. Passive stretching: Supine position, cervical spine stretched just short of restriction, hold for 30s with 20s rest, repeat 3 times.

3. Muscle Energy Technique: Supine position, identify restriction barrier, move spine away from barrier, instruct patient to isometrically contract opposing movement (25% strength), hold for 7-10s, then stretch towards new barrier for 30s, repeat 3 times.

Intervention Type: PROCEDURE

Other Intervention Names

Passive Stretching, Muscle energy Technique

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Peradeniya

OTHER

Sponsor Role: lead

Responsible Party

M.D.M.T.D.Dissanayake

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Hospital Kandy

Kandy, Central Province, Sri Lanka

Site Status: RECRUITING

Countries

Sri Lanka

Central Contacts

Dissanayake

Role: CONTACT

dilmini008.dd@gmail.com

0702797349 ext. +94

Facility Contacts

Meemure D.M.T.D Dissanayake, B.Sc (Hons) in Physiotherapy

Role: primary

dilmini008.dd@gmail.com

+94 702 797 349

Doctor, Master of Philosophy

Role: backup

jayamkd@yahoo.com

+94 812 369 265

Meemure D.M.T.D. Dissanayake, B.Sc (Hons) in Physiotherapy

Role: backup

Other Identifiers

DPTAHS

Identifier Type: -

Identifier Source: org_study_id