Home » Trials » SLCTR/2026/001


EFFECTIVENESS OF MYOFASCIAL RELEASE, MUSCLE ENERGY TECHNIQUE, AND TENS ON PAIN, RANGE OF MOTION, FUNCTIONAL STATUS, AND QUALITY OF LIFE IN ADULTS WITH CHRONIC NON-SPECIFIC NECK PAIN: A RANDOMIZED CONTROLLED TRIAL

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SLCTR Registration Number

SLCTR/2026/001


Date of Registration

09 Jan 2026

The date of last modification

Jan 09, 2026



Application Summary


Scientific Title of Trial

EFFECTIVENESS OF MYOFASCIAL RELEASE, MUSCLE ENERGY TECHNIQUE, AND TENS ON PAIN, RANGE OF MOTION, FUNCTIONAL STATUS, AND QUALITY OF LIFE IN ADULTS WITH CHRONIC NON-SPECIFIC NECK PAIN: A RANDOMIZED CONTROLLED TRIAL


Public Title of Trial

Effectiveness of Myofascial Release and Muscle Energy Technique Compared with Transcutaneous Electrical Nerve Stimulation on Pain, Range of Motion, Functional Status, and Quality of Life in Adults with Chronic Non-Specific Neck Pain: A Randomized Controlled Trial


Disease or Health Condition(s) Studied

Chronic Neck Pain


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1323-9604


Any other number(s) assigned to the trial and issuing authority

2024/EC/64:FoM,UoP


Trial Details


What is the research question being addressed?

In patients with chronic neck pain, does Myofascial Release and Muscle Energy Technique improve pain, cervical range of motion, functional status, and quality of life to a significantly greater degree compared to Transcutaneous Electrical Nerve Stimulation?’


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Data analysts, Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 2


Intervention(s) planned

The study will be conducted in the outpatient physiotherapy department of Nawaloka Hospital, Negombo, Sri Lanka. Eligible participants will be randomly allocated into three groups using a computer-generated randomization sequence. Allocation concealment will be ensured, and both participants and outcome assessors will be blinded to group allocation.

This study consists of three interventions. All interventions will use generic names and follow standardized physiotherapy protocols. Group A – Myofascial Release (MFR) + TENS + Exercises • Type of intervention: Manual therapy (myofascial release) • Procedure: Gentle sustained pressure, cross-hand techniques, soft tissue release to trapezius, levator scapulae, paraspinals. Repeated 5 cycles per muscle group. • Duration per session: 15 minutes • Frequency: 2 sessions per week • Total sessions: 8 sessions (4 weeks) • Combined with: o TENS (see below) for 20 minutes o Exercises: cervical ROM, stretching (30 sec × 3 reps), isometric strengthening (10 sec × 5–10 reps) Group B – Muscle Energy Technique (MET) + TENS + Exercises • Type of intervention: Manual therapy (muscle energy technique – post-isometric relaxation) • Procedure: Patient-generated isometric contractions against therapist resistance followed by passive stretch. Repeated for 5 cycles. • Duration: 15 minutes • Frequency: 2 sessions per week • Total sessions: 8 sessions (4 weeks) • Combined with: o TENS for 20 minutes o Same exercise program as above. Group C – TENS + Exercises (Control Group) • Type of intervention: Electrotherapy (TENS) • Device: Standard TENS device using biphasic asymmetrical rectangular pulses • Electrode placement: Paraspinal cervical region (bilateral) • Parameters: o Frequency: 100 Hz o Pulse width: 200 µs o Intensity: Strong but comfortable (non-painful), without visible muscle contraction • Duration: 20 minutes per session • Frequency: 2 sessions per week • Total sessions: 8 sessions (4 weeks) Combined with: Standard exercise program as above.


Inclusion criteria

• Adults aged 20–40 years * Having chronic non-specific neck pain lasting more than 12 weeks • Pain intensity of VAS ?4 • Both male and female participants Exclusion Criteria • Presence of specific neck pain due to underlying pathology such as cervical disc prolapse, tumor, whiplash injury, cervical fractures, or osteoporosis • Presence of neurological signs consistent with cervical nerve root compression


Exclusion criteria

• Presence of specific neck pain due to underlying pathology such as Cervical disc prolapse, Tumor, Whiplash injury, Cervical fractures, Osteoporosis, presence of neurological signs. • Have pain intensity less than 4 on the VAS scale.



Primary outcome(s)

1.
  1. Pain - Visual analogue scale (VAS) will be used to assess pain severity
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
2.
  1. Range of motion - Universal goniometer will to used to assess the range of motion.
[]
3.
  1. Quality of life - The short-form 36 (SF-36) questionnaire will be used to assess the quality of life of the participants.
[]
4.
  1. Functional status/disability - The neck disability index (NDI) questionnaire will be used to assess the functional status of the participants
[]
5.
  1. Range of motion - Universal goniometer will to used to assess the range of motion.
[]
6.
  1. Quality of life - The short-form 36 (SF-36) questionnaire will be used to assess the quality of life of the participants.
[]
7.
  1. Functional status/disability - The neck disability index (NDI) questionnaire will be used to assess the functional status of the participants
[]
8.
  1. Range of motion - Universal goniometer will to used to assess the range of motion.
[]
9.
  1. Quality of life - The short-form 36 (SF-36) questionnaire will be used to assess the quality of life of the participants.
[]
10.
  1. Functional status/disability - The neck disability index (NDI) questionnaire will be used to assess the functional status of the participants
[]
11.
  1. Range of motion - Universal goniometer will be used to assess the range of motion.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
12.
  1. Quality of life - The short-form 36 (SF-36) questionnaire will be used to assess the quality of life of the participants.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
13.
  1. Functional status/disability - The neck disability index (NDI) questionnaire will be used to assess the functional status of the participants
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
14.
  1. Range of motion - Universal goniometer will be used to assess the range of motion.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
15.
  1. Quality of life - The short-form 36 (SF-36) questionnaire will be used to assess the quality of life of the participants.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
16.
  1. Functional status/disability - The neck disability index (NDI) questionnaire will be used to assess the functional status of the participants
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
17.
  1. Range of motion - Universal goniometer will be used to assess the range of motion.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
18.
  1. Quality of life - The short-form 36 (SF-36) questionnaire will be used to assess the quality of life of the participants.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
19.
  1. Functional status/disability - The neck disability index (NDI) questionnaire will be used to assess the functional status of the participants
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
20.
  1. Range of motion - Universal goniometer will be used to assess the range of motion.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
21.
  1. Quality of life - The short-form 36 (SF-36) questionnaire will be used to assess the quality of life of the participants.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
22.
  1. Functional status/disability - The neck disability index (NDI) questionnaire will be used to assess the functional status of the participants
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
23.
  1. Range of motion - Universal goniometer will be used to assess the range of motion.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
24.
  1. Quality of life - The short-form 36 (SF-36) questionnaire will be used to assess the quality of life of the participants.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
25.
  1. Functional status/disability - The neck disability index (NDI) questionnaire will be used to assess the functional status of the participants
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
26.
  1. Range of motion - Universal goniometer will be used to assess the range of motion.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
27.
  1. Quality of life - The short-form 36 (SF-36) questionnaire will be used to assess the quality of life of the participants.
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]
28.
  1. Functional status/disability - The neck disability index (NDI) questionnaire will be used to assess the functional status of the participants
[

These measurements will be taken on the first day before commencing the intervention and after completion of 8 treatment sessions (2 sessions per week), the post measurements will be taken.

]

Secondary outcome(s)

1.

None

[

None

]

Target number/sample size

93 (31 in each group)


Countries of recruitment


Anticipated start date

2026-01-08


Anticipated end date

2026-04-08


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self funded


Regulatory approvals

N/A



State of Ethics Review Approval


Status

Approved


Date of Approval

2025-05-19


Approval number

2024/EC/64


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Peradeniya
Institutional Address:Faculty of Medicine, University of Peradeniya
Telephone:0812396361
Email: chairperson.erc@med.pdn.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

S.M.Joseph
Post graduate student (MSc in Physiotherapy)
Department of Physiotherapy Faculty of Allied Health Sciences, University of Peradeniya, Augusta Hill, Sri Amarawansa Mawatha, Peradeniys
0813999623
0779870744

stefyphysio@gmail.com
ahs.pdn.ac.lk

Contact Person for Public Queries

Ms. D.A.R.K. Dassanayaka
Senior Lecturer
Faculty of Allied Health Sciences, University of Peradeniya.
0763859789
0763859789

renukadasanayaka@gmail.com
ahs.pdn.ac.lk


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results