NCT05925205

Brief Summary

This study will be conducted to examine the superiority of effectiveness between muscle energy technique combined with physical therapy, strain counterstrain combined with physical therapy, and physical therapy alone in terms of pain intensity, pain pressure threshold, cervical lateral flexion and rotation range of motion, and neck function for patients with upper trapezius myofascial trigger points.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

May 7, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 21, 2023

Last Update Submit

June 21, 2023

Conditions

Keywords

Muscle energy technique, strain counterstrain, trapezius.

Outcome Measures

Primary Outcomes (10)

  • Change in pain intensity.

    Measurement of pain intensity using the visual analogue scale.

    Change from Baseline pain intensity at one month.

  • Change in the right side pain pressure threshold.

    Measurement of right side pain pressure threshold using the pressure algometer.

    Change from Baseline right side pain pressure threshold at one month.

  • Change in the left side pain pressure threshold.

    Measurement of left side pain pressure threshold using the pressure algometer.

    Change from Baseline left side pain pressure threshold at one month.

  • Change in cervical flexion range of motion.

    Measurement of cervical flexion range of motion using the cervical range of motion device.

    Change from Baseline cervical flexion range of motion at one month.

  • Change in cervical extension range of motion.

    Measurement of cervical extension range of motion using the cervical range of motion device.

    Change from Baseline cervical extension range of motion at one month.

  • Change in cervical right lateral flexion range of motion.

    Measurement of cervical right lateral flexion range of motion using the cervical range of motion device.

    Change from Baseline cervical right lateral flexion range of motion at one month.

  • Change in cervical left lateral flexion range of motion.

    Measurement of cervical left lateral flexion range of motion using the cervical range of motion device.

    Change from Baseline cervical left lateral flexion range of motion at one month.

  • Change in cervical right rotation range of motion.

    Measurement of cervical right rotation range of motion using the cervical range of motion device.

    Change from Baseline cervical right rotation range of motion at one month.

  • Change in cervical left rotation range of motion.

    Measurement of cervical left rotation range of motion using the cervical range of motion device.

    Change from Baseline cervical left rotation range of motion at one month.

  • Change in neck function.

    Measurement of neck function using the neck disability index-Arabic version.

    Change from Baseline neck function at one month.

Study Arms (3)

Group A

EXPERIMENTAL

Experimental group 1.

Procedure: Muscle energy technique combined with the physical therapy program.

Group B

EXPERIMENTAL

Experimental group 2.

Procedure: Strain counterstrain technique combined with the physical therapy program

Group C

EXPERIMENTAL

Experimental group 3.

Procedure: The physical therapy program

Interventions

Electrotherapy and exercise.

Group C

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients will be included in the study if they fulfil the following criteria:
  • They have active myofascial trigger points in the upper trapezius muscle bilaterally according to the established criteria for myofascial trigger points examination.
  • They have neck pain less than three months.

You may not qualify if:

  • Patients will be excluded from the study if they fulfil the following criteria:
  • Patients with chronic pain syndrome.
  • Patients having myofascial trigger points in other neck muscles.
  • Patients having a history of an injury or surgery or instability or deformity including both; cervical spine and shoulder.
  • Patients diagnosed with a neurological disorder including altered sensation, migraine, cervical spondylosis, radiculopathy, or myelopathy, and tumour.
  • Patients with a systemic disease including rheumatoid arthritis, Reiter's syndrome, diabetes, fibromyalgia syndrome, and severe medical or psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University

Kafr ash Shaykh, Egypt

RECRUITING

Study Officials

  • Bassem El Nahass, PhD

    Professor of Orthopaedic Physical Therapy, Faculty of Physical Therapy, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Haytham Morsi, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Firstly, the research assistant, another qualified physical therapist, performing the assessment process, pre and post-treatment, will be blinded regarding the patients allocation into the three treatment groups. Secondly, the patients themselves will be blinded regarding which treatment group they will be allocated into. So the research assistant won't know the randomization results, and the main investigator won't know the assessment results which will make it a double-blinded study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2023

First Posted

June 29, 2023

Study Start

May 7, 2023

Primary Completion

May 7, 2024

Study Completion

December 31, 2024

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations