- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06750211
Effect of MET With and Without MCTE in Mechanical Neck Pain
December 20, 2024 updated by: Riphah International University
Effects of Muscle Energy Techniques With and Without Motor Control Therapeutic Exercises on Pain, Range of Motion and Disability in Patients With Mechanical Neck Pain.
Work had to be done previously on METs and MCTE techniques, but no study has compared both techniques together to make it more comprehensible.
The rationale of this will be to find out the combined effect of motor control therapeutic exercises and muscle energy technique for the treatment of pain, range of motion and disability associated with mechanical neck pain.
This study will be effective for the clinicians to treat patients of mechanical neck pain.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Therapeutic exercises and manual therapy were shown to be useful in managing pain and lowering disability in patients with non-specific chronic neck pain (NCNP).
However, little studies investigated the benefits of muscle energy technique and motor control therapeutics exercise on mechanical neck pain (MNP).
The current research fulfill this gap by comparing the short and long term benefits of muscle energy technique with and without motor control therapeutic exercises (MCTE) with the grail of determining best approach for lowering pain and disability in mechanical neck pain patients.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
-
Lahore, Pakistan, 54660
- Recruiting
- Riphah college of rehabilitation and allied health sciences
-
Contact:
- saba Rafique, phd
- Email: saba.rafique@riphah.edu.pk
-
Principal Investigator:
- Maham Javed, MS-OMPT
-
Sub-Investigator:
- Dr.Ali Raza, phd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
• Subjects were between 20 and 50 years old.
- Pain in cervical or neck region with no radiating pain in one or both upper limbs.
- Pain minimum of 3 months.
- Neck disability index (NDI) score of should be at least 10%.
- Forward head posture.
Exclusion Criteria:
• Neck pain associated with vertigo.
- Irradiated neck pain.
- Vertebral fracture.
- Osteoporosis.
- Previous neck injury.
- Red flags (night pain, severe muscle loss, loss of involuntary control.
- Subjects with difficulty in communication or understanding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: METs
Hot pack along with Neck isometrics and muscle energy technique protocol
|
Patient came thrice per week for a total of 4 weeks. |
|
Experimental: MCTE along with METs
MCTE included cranio-cervical flexion, cranio-cervical extension, co-contraction of flexion and extension and synergistic exercise of neck flexor along with hot pack, neck isometrics and muscle energy technique protocol
|
▪ Hot pack for 10 minutes.
All exercises were performed three times per week for total of 4 weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain scale rating
Time Frame: 4th week
|
Changes from base line Pain intensity was assessed by Numeric Rating Scale (NRS).
NRPS has fair to moderate reliability of test-retest in patients with Mechanical Neck Pain.
The patient was required to indicate the number that represent his intensity of pain, in which 0 represents "no pain" and 10 represents "the worst pain imaginable".
Numeric Pain Rating Scale is widely used subjective pain measure that has good test-retest reliability r = 0.79 - 0.96
|
4th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck disability index
Time Frame: 4th week
|
Changes from base line NDI is self-assessment tool for the specific functional status of patients with neck pain, consisting of ten components pain, personal hygiene, obesity, reading, headache, focus, work, travelling, sleeping, and leisure, each part is scored on an index of 0 to 5, with 0 representing "painless" and 5 representing the "worst pain imaginable".
These points earned are added to the total score.
The questionnaire was determined in percentage.
The NDI disability categories are: 0-8% without disability, 10-28% mild, 30-48% moderate, 50-64% serious, and 70-100% complete.
NDI has fair to moderate reliability of test-retest in patients, with inter-class correlation coefficient ranging from 0.50-0.98.
|
4th week
|
|
ROM cervical spine (flexion)
Time Frame: 4th week
|
Changes from base line Universal Goniometer is used for measuring neck range of motion.
Reliability of goniometer was found for all the measurements ranging from, interclass correlation coefficient for goniometer > 0.94.
The concurrent validity of goniometer was good with ICC value of > 0.85.
The goniometer will be used to measure flexion.
|
4th week
|
|
ROM cervical spine (Extension)
Time Frame: 4th week
|
Changes from base line Universal Goniometer is used for measuring neck range of motion.
Reliability of goniometer was found for all the measurements ranging from, interclass correlation coefficient for goniometer > 0.94.
The concurrent validity of goniometer was good with ICC value of > 0.85.
The goniometer will be used to measure extension.
|
4th week
|
|
ROM cervical spine (Side flexion)
Time Frame: 4th week
|
Changes from base line Universal Goniometer is used for measuring neck range of motion.
Reliability of goniometer was found for all the measurements ranging from, interclass correlation coefficient for goniometer > 0.94.
The concurrent validity of goniometer was good with ICC value of > 0.85.
The goniometer will be used to measure side flexion.
|
4th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Saba Rafique, PhD, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
- Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.
- Letafatkar A, Rabiei P, Alamooti G, Bertozzi L, Farivar N, Afshari M. Effect of therapeutic exercise routine on pain, disability, posture, and health status in dentists with chronic neck pain: a randomized controlled trial. Int Arch Occup Environ Health. 2020 Apr;93(3):281-290. doi: 10.1007/s00420-019-01480-x. Epub 2019 Oct 25.
- Parikh P, Santaguida P, Macdermid J, Gross A, Eshtiaghi A. Comparison of CPG's for the diagnosis, prognosis and management of non-specific neck pain: a systematic review. BMC Musculoskelet Disord. 2019 Feb 14;20(1):81. doi: 10.1186/s12891-019-2441-3.
- Martin-Gomez C, Sestelo-Diaz R, Carrillo-Sanjuan V, Navarro-Santana MJ, Bardon-Romero J, Plaza-Manzano G. Motor control using cranio-cervical flexion exercises versus other treatments for non-specific chronic neck pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2019 Jul;42:52-59. doi: 10.1016/j.msksp.2019.04.010. Epub 2019 Apr 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 4, 2024
Primary Completion (Estimated)
January 7, 2025
Study Completion (Estimated)
January 8, 2025
Study Registration Dates
First Submitted
December 20, 2024
First Submitted That Met QC Criteria
December 20, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 20, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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