NCT06780904

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 17, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 31, 2024

Last Update Submit

January 15, 2025

Conditions

Keywords

myofascial trigger pointspassive stretchingdry needlingMuscle Energy Technique (MET)Randomized clinical trialUpper trapezius

Outcome Measures

Primary Outcomes (1)

  • Neck pain

    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.

    2 weeks

Secondary Outcomes (2)

  • Neck Range of Motion

    2 weeks

  • Neck disability level

    2 weeks

Study Arms (2)

Treatment group 1

ACTIVE COMPARATOR

Dry needling + Passive stretching

Procedure: Dry Needling

Treatment group 2

OTHER

Dry needling + Muscle Energy technique

Procedure: Dry Needling

Interventions

Dry NeedlingPROCEDURE

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.

Also known as: Passive Stretching, Muscle energy Technique
Treatment group 1Treatment group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Hospital Kandy

Kandy, Central Province, 20000, Sri Lanka

RECRUITING

MeSH Terms

Conditions

Neck Pain

Interventions

Dry NeedlingMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded (Participants)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 17, 2025

Study Start

September 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

January 17, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations