NCT07672028

Brief Summary

This randomized clinical trial will compare the effectiveness of ERGON Therapy combined with Muscle Energy Technique (MET) versus ERGON Therapy alone in patients with mechanical neck pain. Participants will be randomly assigned to one of two intervention groups. Both groups will receive conventional physiotherapy consisting of Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises. The study will evaluate changes in pain intensity, cervical range of motion, and functional disability. The findings are expected to provide evidence regarding the added benefit of MET when combined with ERGON Therapy in the management of mechanical neck pain.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

December 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

June 22, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

Mechanical Neck PainMuscle Energy TechniqueInstrument-Assisted Soft Tissue MobilizationERGON TherapyManual Therapy

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity (NPRS)

    Pain intensity will be assessed using the Numeric Pain Rating Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.

    Baseline and after completion of 6 treatment sessions (2 weeks)

  • Cervical Range of Motion (CROM)

    Cervical range of motion refers to the measurement of movement of the cervical spine in different planes, including flexion, extension, lateral flexion, and rotation. It reflects neck mobility and functional joint movement and will be assessed using standard clinical methods at baseline and post-intervention.

    Baseline and after completion of 6 treatment sessions over 2 weeks

Secondary Outcomes (1)

  • Functional Disability (Neck Disability Index - NDI)

    Baseline and after completion of 6 treatment sessions over 2 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

ERGON Therapy combined with Muscle Energy Technique plus conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.

Other: Instrument-Assisted Soft Tissue Mobilization (ERGON Technique) Muscle Energy Technique Conventional Physiotherapy

Comparator Group

ACTIVE COMPARATOR

ERGON Therapy alone plus conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.

Other: Instrument-Assisted Soft Tissue Mobilization (ERGON Technique) Conventional Physiotherapy

Interventions

Participants in the experimental group will receive Instrument-Assisted Soft Tissue Mobilization using ERGON technique combined with Muscle Energy Technique. ERGON therapy will be applied to cervical soft tissues to improve tissue mobility and reduce pain. Muscle Energy Technique will be used to facilitate joint mobility and reduce muscular tightness. In addition, participants will receive conventional physiotherapy including Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises.

Also known as: TENS, Hot Pack, Cervical Stretching
Experimental Group

Participants in the comparator group will receive Instrument-Assisted Soft Tissue Mobilization using ERGON technique alone. ERGON therapy will be applied to cervical soft tissues to improve tissue mobility and reduce pain. In addition, participants will receive the same conventional physiotherapy protocol including Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises.

Also known as: TENS, Hot Pack, Cervical Stretching
Comparator Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals clinically diagnosed with mechanical neck pain Duration of neck pain of at least 2 weeks Willingness to participate and provide written informed consent

You may not qualify if:

  • History of cervical spine surgery within the past 12 months History of trauma or infection in the cervical region Presence of neurological deficits or cervical radiculopathy Presence of systemic disorders affecting musculoskeletal function Any other musculoskeletal deformity or significant disability affecting the neck region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bethania Hospital

Sialkot, 54910, Pakistan

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • DANYAL AHMAD

    University of Management and Technology Sialkot Pakistan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to two parallel groups. One group will receive ERGON Therapy combined with Muscle Energy Technique, while the other group will receive ERGON Therapy alone. Both groups will also receive conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start

December 1, 2025

Primary Completion

July 15, 2026

Study Completion

July 30, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data including baseline characteristics (age, gender), pain scores (Numeric Pain Rating Scale), cervical range of motion measurements, and Neck Disability Index scores will be shared. No personal identifiers such as names, contact details, or hospital record numbers will be included.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
IPD will be available beginning 6 months after study completion and will remain available for 5 years after study completion.
Access Criteria
De-identified individual participant data including baseline characteristics (age, gender), pain scores (Numeric Pain Rating Scale), cervical range of motion measurements, and Neck Disability Index scores will be shared. No personally identifiable information such as names, contact numbers, or hospital identification numbers will be included. Supporting study documents such as study protocol and data collection forms may also be made available.
More information

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