Neck PainNCT05315076
Comparison of Thoracic Manipulation and Muscle Energy Technique in Non-specific Mechanical Neck Pain
A study testing thoracic Manipulation Posterior anterior and conventional therapy and Muscle Energy Technique (PIR) and conventional treatment in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of Thoracic manipulation and MET in relieving pain.in improving Range of motion and in improving functional disability. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- thoracic Manipulation Posterior anterior and conventional therapy and Muscle Energy Technique (PIR) and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who present with a primary complaint of mechanical neck pain (defined as pain in the region between the superior nuchal line and first thoracic spinous process) with limited Range of motion.
- Patients with non-radiating neck pain of moderate intensity scoring 4-8 on the numeric pain rating scale (NPRS).
- Subacute or chronic cases (4 -12 weeks)
- Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale)
- Dull aching neck pain increased by sustained postures, neck movement
Who cannot join
- Patients with a positive history of trauma, fracture or surgery of the cervical spine.
- Neck pain with radiation to the arm and upper extremity
- Diagnosed cases of torticollis, and scoliosis
- History of osteoporosis, Any heart disease
- Taken previous physiotherapy session.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the effects of Thoracic manipulation and MET in relieving pain.in improving Range of motion and in improving functional disability.
Read the detailed description
Neck pain is a common musculoskeletal disorder. Mechanical neck pain is also known as non-specific neck pain and is defined as the pain anywhere within the region bounded superiorly by superior nuchal line, inferiorly by an imaginary line through the tip of first thoracic spinous process and laterally by sagittal plane tangential to the lateral borders of the neck in which pain is provoked by sustained neck posture, neck movement, pain on palpation of cervical musculature without pathologies. In most patients, neck pain can be a common cause of disability: it is associated with daily activity limitations, reduction of work productivity and decrease in quality of life. Mechanical neck pain is commonly seen in people involved in occupation like computer processing, clerical job, students and people with sedentary life style awkward occupational posture, heavy lifting and physically demanding work.
thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine.
Muscle energy technique (MET) is a method of treatment that involves the voluntary contraction of subject's muscles in a precisely controlled direction, against a counterforce and producing post isometric relaxation through the influence of the Golgi tendon. MET is used to decrease pain, stretch tight structures muscle and fascia, reduce muscle tone, improve local circulation, and mobilize joint restriction
- Conditions
- Neck Pain
- Being tested
- thoracic Manipulation Posterior anterior and conventional therapy, Muscle Energy Technique (PIR) and conventional treatment
- Keywords
- Pain, thoracic manipulation, muscle energy technique, disability, range of motion
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic Manipulation Posterior anterior and conventional therapyOther
A high-velocity, end range force directed to both sides of the respective zygapophyseal joint as indicated by the segmental examination. This procedure will be performed for a maximum of two attempts. When a cracking sound occurred, the therapist will move on to the next segmental restriction from an upper level to a lower level.
Muscle Energy Technique (PIR) and conventional treatmentOther
sustain the Isometric contraction for 7-10 and hold the breath. Then the patient will be asked to breathe out and relax while the therapist stretches further up to the neck barrier and hold this for 30 seconds.3 to 5 repetition
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Manipulation Posterior anterior and conventional therapy | Experimental | Thoracic Manipulation Posterior anterior and conventional therapy Receives: Other: thoracic Manipulation Posterior anterior and conventional therapy; Other: Muscle Energy Technique (PIR) and conventional treatment |
| Muscle Energy Technique (PIR) and conventional treatment | Experimental | Muscle Energy Technique (PIR) and conventional treatment Receives: Other: thoracic Manipulation Posterior anterior and conventional therapy; Other: Muscle Energy Technique (PIR) and conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable.Assesment to be done at baseline,1st session,3rd session and 6th session.
Measured: three weeks
Inclinometer
it is used for measurements of cervical flexion, extension, lateral flexion, and rotation.Assesment to be done at baseline,1st session,3rd session and 6th session.
Measured: three weeks
Neck Disability Index
The neck disability index is a ten-item self-reported questionnaire that assesses pain and associated disability, with a total max score of 50 points. .Assessment to be done at baseline,1st session,3rd session and 6th session.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Feb 2023
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315076
- Sponsor's protocol ID
- REC 01211 Muhammad Saad Hassan
- Status last verified
- Feb 2023
- First submitted
- 30 Mar 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thoracic Manipulation and Muscle Energy Technique in Non-specific Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05315076
- Acronym / sponsor ID
- REC 01211 Muhammad Saad Hassan
- Conditions
- Neck Pain
- Keywords
- Pain, thoracic manipulation, muscle energy technique, disability, range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 7 Apr 2022 (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.
To compare the effects of Thoracic manipulation and MET in relieving pain.in improving Range of motion and in improving functional disability.
Detailed description
Neck pain is a common musculoskeletal disorder. Mechanical neck pain is also known as non-specific neck pain and is defined as the pain anywhere within the region bounded superiorly by superior nuchal line, inferiorly by an imaginary line through the tip of first thoracic spinous process and laterally by sagittal plane tangential to the lateral borders of the neck in which pain is provoked by sustained neck posture, neck movement, pain on palpation of cervical musculature without pathologies. In most patients, neck pain can be a common cause of disability: it is associated with daily activity limitations, reduction of work productivity and decrease in quality of life. Mechanical neck pain is commonly seen in people involved in occupation like computer processing, clerical job, students and people with sedentary life style awkward occupational posture, heavy lifting and physically demanding work.
thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine.
Muscle energy technique (MET) is a method of treatment that involves the voluntary contraction of subject's muscles in a precisely controlled direction, against a counterforce and producing post isometric relaxation through the influence of the Golgi tendon. MET is used to decrease pain, stretch tight structures muscle and fascia, reduce muscle tone, improve local circulation, and mobilize joint restriction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Manipulation Posterior anterior and conventional therapy | Experimental | Other: thoracic Manipulation Posterior anterior and conventional therapy, Other: Muscle Energy Technique (PIR) and conventional treatmentThoracic Manipulation Posterior anterior and conventional therapy |
| Muscle Energy Technique (PIR) and conventional treatment | Experimental | Other: thoracic Manipulation Posterior anterior and conventional therapy, Other: Muscle Energy Technique (PIR) and conventional treatmentMuscle Energy Technique (PIR) and conventional treatment |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who present with a primary complaint of mechanical neck pain (defined as pain in the region between the superior nuchal line and first thoracic spinous process) with limited Range of motion.
- Patients with non-radiating neck pain of moderate intensity scoring 4-8 on the numeric pain rating scale (NPRS).
- Subacute or chronic cases (4 -12 weeks)
- Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale)
- Dull aching neck pain increased by sustained postures, neck movement
Key exclusion criteria (5 listed)
- Patients with a positive history of trauma, fracture or surgery of the cervical spine.
- Neck pain with radiation to the arm and upper extremity
- Diagnosed cases of torticollis, and scoliosis
- History of osteoporosis, Any heart disease
- Taken previous physiotherapy session.
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 |
|---|---|---|
| thoracic Manipulation Posterior anterior and conventional therapyA high-velocity, end range force directed to both sides of the respective zygapophyseal joint as indicated by the segmental examination. This procedure will be performed for a maximum of two attempts. When a cracking sound occurred, the therapist will move on to the next segmental restriction from an upper level to a lower level. | Other | Muscle Energy Technique (PIR) and conventional treatment, Thoracic Manipulation Posterior anterior and conventional therapy |
| Muscle Energy Technique (PIR) and conventional treatmentsustain the Isometric contraction for 7-10 and hold the breath. Then the patient will be asked to breathe out and relax while the therapist stretches further up to the neck barrier and hold this for 30 seconds.3 to 5 repetition | Other | Muscle Energy Technique (PIR) and conventional treatment, Thoracic Manipulation Posterior anterior and conventional therapy |
Primary outcome
Numeric Pain Rating Scale
Time frame: three weeks
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable.Assesment to be done at baseline,1st session,3rd session and 6th session.
Inclinometer
Time frame: three weeks
it is used for measurements of cervical flexion, extension, lateral flexion, and rotation.Assesment to be done at baseline,1st session,3rd session and 6th session.
Neck Disability Index
Time frame: three weeks
The neck disability index is a ten-item self-reported questionnaire that assesses pain and associated disability, with a total max score of 50 points. .Assessment to be done at baseline,1st session,3rd session and 6th session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- 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. This study is not recruiting at the moment.
Maria Khalid, MSOMPT 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 thoracic Manipulation Posterior anterior and conventional therapy and Muscle Energy Technique (PIR) and conventional treatment in people with 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 5 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: finished, as of the sponsor's last update on 21 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: three weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2023.