Mechanical Neck PainNCT06750211
Effect of MET With and Without MCTE in Mechanical Neck Pain
A study testing METs and MCTE along with METs in people with Mechanical Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Neck Pain
- What is being tested?
- METs and MCTE along with METs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Jul 2024to 8 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah college of rehabilitation and allied health sciences
Lahore, 54660
saba Rafique, phd, saba.rafique@riphah.edu.pk
Maham Javed, MS-OMPT
About this study
Official title: 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.
Read the 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.
- Conditions
- Mechanical Neck Pain
- Being tested
- METs, MCTE along with METs
- Keywords
- Neck pain, Range of motion, Muscle energy technique, Motor control therapeutic exercise
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METsOther
- Hot pack for 10 minutes.
- Neck isometrics with 10 second hold.
- Each series of neck isometrics strengthening exercises had three movements including cervical flexion, cervical extension and cervical side flexion.
- Muscle energy technique protocol: The individual was in a position of supine. The therapist was at the edge of bed, near the participants head. the therapist positioned the joint at the point of beginning range of motion resistance when performing a given movement. When the therapist felt restriction, positioned the cervical spine in that region and apply the resistive force. Patient was instructed to contract isometrically for five seconds without exceeding the therapist force. thereafter, therapist counterforce gradually reduced and patient was asked to relaxed. Therapist move the joint into new point of barrier and same protocol repeated three times.
Patient came thrice per week for a total of 4 weeks.
MCTE along with METsOther
▪ Hot pack for 10 minutes.
- Neck isometrics with 10 second hold.
- Each series of neck isometrics strengthening exercises had three movements including cervical flexion, cervical extension and cervical side flexion.
- After it was treated with motor control therapeutic exercises together with muscle energy technique. Motor control therapeutic exercises included cranio-cervical flexor exercises, cranio-cervical extensor exercises, co contraction of flexor and extensor and synergy exercise for strengthening deep neck flexor. Exercises were performed in three sets with 10 repetitions with an approximate duration of 10 to 20 minutes. They were advised to perform at home once in a day, five times in a week for a duration of 4 weeks.
All exercises were performed three times per week for total of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| METs | Active comparator | Hot pack along with Neck isometrics and muscle energy technique protocol Receives: Other: METs |
| MCTE along with METs | Experimental | 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 Receives: Other: MCTE along with METs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain scale rating
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
Measured: 4th week
Secondary outcomes (4)
Neck disability index
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.
Measured: 4th week
ROM cervical spine (flexion)
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.
Measured: 4th week
ROM cervical spine (Extension)
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.
Measured: 4th week
ROM cervical spine (Side flexion)
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.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start4 Jul 2024
- Primary completion7 Jan 2025 (estimated)
- Study completion8 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mechanical Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Rafique, phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750211
- Sponsor's protocol ID
- REC/RCR & AHS/24/0115
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31654125Bernal-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.
PubMed 32723399Martin-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.
PubMed 31030111Parikh 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.
PubMed 30764789Hidalgo 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.
PubMed 28826164
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06750211
- Acronym / sponsor ID
- REC/RCR & AHS/24/0115
- Conditions
- Mechanical Neck Pain
- Keywords
- Neck pain, Range of motion, Muscle energy technique, Motor control therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 8 Jan 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| METs | Active comparator | Other: METsHot pack along with Neck isometrics and muscle energy technique protocol |
| MCTE along with METs | Experimental | Other: MCTE along with METsMCTE 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Subjects were between 20 and 50 years old.
Key exclusion criteria (7 listed)
- • Neck pain associated with vertigo.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| METs* Hot pack for 10 minutes. * Neck isometrics with 10 second hold. * Each series of neck isometrics strengthening exercises had three movements including cervical flexion, cervical extension and cervical side flexion. * Muscle energy technique protocol: The individual was in a position of supine. The therapist was at the edge of bed, near the participants head. the therapist positioned the joint at the point of beginning range of motion resistance when performing a given movement. When the therapist felt restriction, positioned the cervical spine in that region and apply the resistive force. Patient was instructed to contract isometrically for five seconds without exceeding the therapist force. thereafter, therapist counterforce gradually reduced and patient was asked to relaxed. Therapist move the joint into new point of barrier and same protocol repeated three times. Patient came thrice per week for a total of 4 weeks. | Other | METs |
| MCTE along with METs▪ Hot pack for 10 minutes. * Neck isometrics with 10 second hold. * Each series of neck isometrics strengthening exercises had three movements including cervical flexion, cervical extension and cervical side flexion. * After it was treated with motor control therapeutic exercises together with muscle energy technique. Motor control therapeutic exercises included cranio-cervical flexor exercises, cranio-cervical extensor exercises, co contraction of flexor and extensor and synergy exercise for strengthening deep neck flexor. Exercises were performed in three sets with 10 repetitions with an approximate duration of 10 to 20 minutes. They were advised to perform at home once in a day, five times in a week for a duration of 4 weeks. All exercises were performed three times per week for total of 4 weeks. | Other | MCTE along with METs |
Primary outcome
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
4 secondary outcomes
Neck disability index
Time frame: 4th week
ROM cervical spine (flexion)
Time frame: 4th week
ROM cervical spine (Extension)
Time frame: 4th week
ROM cervical spine (Side flexion)
Time frame: 4th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 31654125Letafatkar 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.
- Background: PubMed 32723399Bernal-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.
- Background: PubMed 31030111Martin-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.
- Background: PubMed 30764789Parikh 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.
- Background: PubMed 28826164Hidalgo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saba Rafique, phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing METs and MCTE along with METs in people with Mechanical Neck Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain scale rating (time frame: 4th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750211, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.