Cervical PainNCT05762289
Comparison of Weight Bearing Thrust Manipulation With Non Weightbearing Thrust Manipulation in Patients With Forward Head Posture
A study testing Thrust Manipulation (in weight bearing and non weight bearing) in people with Cervical Pain, run by Yusra Medical and Dental College at 1 site in Pakistan.
Trial summary
This randomized controlled trial was performed in MMRC (Majestic medicine rehabilitation Sciences) Islamabad in February 2023 and consisted of patients having neck pain and forward head posture. 30 Patients were divided into two groups of 15 each by sealed envelope method . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Thrust Manipulation (in weight bearing and non weight bearing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2023to 15 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Forward head posture
- Patients who had complain of neck pain
- Decrease range of flexion, extension, rotation and side flexion of cervical spine
- Craniovertebral angle below 48 were included
Who cannot join
- Patients with structural or anatomical deformity,
- recent surgical history , degenerative changes ,
- cervical instability,
- malignancy
- radiculopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial Comparing the Immediate Effects Cervical Thrust Manipulation in Weight Bearing and Non Weight Bearing Position for Improving Cervical Range of Motion and Pain in Forward Head Posture
This randomized controlled trial was performed in MMRC (Majestic medicine rehabilitation Sciences) Islamabad in February 2023 and consisted of patients having neck pain and forward head posture. 30 Patients were divided into two groups of 15 each by sealed envelope method . Treatment group was given weight bearing thrust manipulation in sitting and control was given non weight bearing thrust manipulation in supine lying. Pain was calculated through NPRS and Cervical ranges were calculated by Inclinometer before and immediately after treatment.
Read the detailed description
Cervical Spine is most integral part of human spine as it sits between highly stable thoracic and highly movable occipital bodies. It help the head movement of flexion , rotation which are constantly required for performing basic activities of daily life. It is a link between head and rest of the body and due to its need in mobility it is often put under greater stress , muscular imbalance, reduced disc spaces and common site for many spinous syndromes. One of the most common disability that occurs on cervical spine is forward headv posture usually associated with upper crossed syndrome and is known as text neck also due to strain put on spine due to high usage of screen devices. Sedentary lifestyle and postural imbalances and effect of gravity are usually the major causes of muscular and bony imbalances that result in forward head posture. Prolonged state of stress on muscles usually result in pain in neck specially during movement.
High Velocity Low Amplitude Thrust (HVLAT) is a common technique to unlock cervical joints and muscular pain associated with it and immediately reduce pain. Cavitation sound or pop is often associated with this thrust technique that is result decrease in pressure causes dissolved gasses in the synovial fluid to be released into the joint cavity of due to which , the force-displacement curve shifts and the range of motion of the joint increases.It has been stated that spinal manipulation activates presynaptic inhibition of segmental pain pathways, reflex muscle relaxation, and reflex pain Inhibition. It has been repeatedly proved by literature that thrust manupulation is an effective was of increasing ROM and pain in patients in non weight bearing positions but it can also be given in weight bearing position effects of which are yet not very clear specially in patient population such as forward head posture .The current study was planned to compare the effectiveness of thrust manipulation in weight bearing and non weight bearing postions on pain and range in forward head posture . The hypothesis was that there will be significant difference in the effect of thrust manipulation in different positions.
- Conditions
- Cervical Pain
- Being tested
- Thrust Manipulation (in weight bearing and non weight bearing)
- Keywords
- forward head posture, cervical thrust manipulation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrust Manipulation (in weight bearing and non weight bearing)Other
Pain and Range of cervical motion was assessed before and after manipulation in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Change in range of motion and within the weight bearing group | Experimental | . Subjects in Group A or treatment group were seated and given thrust manipulation using belt. Cervical spine was placed in neutral position and belt was stabilized on C4-C5 which is the part that causes most stiffness and pain and lost of range. Patient placed belt in left hand for left sided thrust and caudal force was applied , therapist held other end of the belt and applied stretch in the line of eye ball. The cervical spine of patient was guided in left rotation until resistance was felt and than thrust of high velocity low amplitude was given by therapist . This was done for both sides if the cavitation sound was not heard manipulation was tried for a second time after 10 minutes by repositioning the patient but no more than two times in a day. Therapist performing manipulation was skilled in giving belt thrust manipulation. Receives: Other: Thrust Manipulation (in weight bearing and non weight bearing) |
| Control | Active comparator | While Group B received manipulation in supine position by maitland's traditional thrust. Where the neck is slightly flexed by therapist hand on the occipit where therapist is standing behind the head. Neck is guided in right side flexion and opposite rotation and at the end of rang high velocity low amplitude thrust is applied. This was done for both sides if the cavitation sound was not heard manipulation was tried for a second time after 10 minutes by repositioning the patient but no more than two times in a day Receives: Other: Thrust Manipulation (in weight bearing and non weight bearing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck pain before and after thrust manipulation
pain will be calculated using Numeric pain rating scale(NPRS) before and after manipulation
Measured: As immediate effects are measured pain before giving manipulation and 10minutes after session is measured
Change in Cervical Range of motion before and after thrust manipulation
Range Of Motion will be measured using inclinometer before and after manipulation
Measured: As immediate effects are measured ranges of motion before giving manipulation and 10minutes after session is meas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Feb 2023
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- 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
- Yusra Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maham Nasir, Yusra Medical and Dental College
- Investigators
- Maham Nasir, DPT, Principal investigator, Yusra institute of Rehabilitation sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762289
- Sponsor's protocol ID
- YusraMDC
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Comparing the Immediate Effects Cervical Thrust Manipulation in Weight Bearing and Non Weight Bearing Position for Improving Cervical Range of Motion and Pain in Forward Head Posture
- ClinicalTrials.gov ID
- NCT05762289
- Acronym / sponsor ID
- YusraMDC
- Conditions
- Cervical Pain
- Keywords
- forward head posture, cervical thrust manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yusra Medical and Dental CollegeUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 9 Mar 2023 (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.
This randomized controlled trial was performed in MMRC (Majestic medicine rehabilitation Sciences) Islamabad in February 2023 and consisted of patients having neck pain and forward head posture. 30 Patients were divided into two groups of 15 each by sealed envelope method . Treatment group was given weight bearing thrust manipulation in sitting and control was given non weight bearing thrust manipulation in supine lying. Pain was calculated through NPRS and Cervical ranges were calculated by Inclinometer before and immediately after treatment.
Detailed description
Cervical Spine is most integral part of human spine as it sits between highly stable thoracic and highly movable occipital bodies. It help the head movement of flexion , rotation which are constantly required for performing basic activities of daily life. It is a link between head and rest of the body and due to its need in mobility it is often put under greater stress , muscular imbalance, reduced disc spaces and common site for many spinous syndromes. One of the most common disability that occurs on cervical spine is forward headv posture usually associated with upper crossed syndrome and is known as text neck also due to strain put on spine due to high usage of screen devices. Sedentary lifestyle and postural imbalances and effect of gravity are usually the major causes of muscular and bony imbalances that result in forward head posture. Prolonged state of stress on muscles usually result in pain in neck specially during movement.
High Velocity Low Amplitude Thrust (HVLAT) is a common technique to unlock cervical joints and muscular pain associated with it and immediately reduce pain. Cavitation sound or pop is often associated with this thrust technique that is result decrease in pressure causes dissolved gasses in the synovial fluid to be released into the joint cavity of due to which , the force-displacement curve shifts and the range of motion of the joint increases.It has been stated that spinal manipulation activates presynaptic inhibition of segmental pain pathways, reflex muscle relaxation, and reflex pain Inhibition. It has been repeatedly proved by literature that thrust manupulation is an effective was of increasing ROM and pain in patients in non weight bearing positions but it can also be given in weight bearing position effects of which are yet not very clear specially in patient population such as forward head posture .The current study was planned to compare the effectiveness of thrust manipulation in weight bearing and non weight bearing postions on pain and range in forward head posture . The hypothesis was that there will be significant difference in the effect of thrust manipulation in different positions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Change in range of motion and within the weight bearing group | Experimental | Other: Thrust Manipulation (in weight bearing and non weight bearing). Subjects in Group A or treatment group were seated and given thrust manipulation using belt. Cervical spine was placed in neutral position and belt was stabilized on C4-C5 which is the part that causes most stiffness and pain and lost of range. Patient placed belt in left hand for left sided thrust and caudal force was applied , therapist held other end of the belt and applied stretch in the line of eye ball. The cervical spine of patient was guided in left rotation until resistance was felt and than thrust of high velocity low amplitude was given by therapist . This was done for both sides if the cavitation sound was not heard manipulation was tried for a second time after 10 minutes by repositioning the patient but no more than two times in a day. Therapist performing manipulation was skilled in giving belt thrust manipulation. |
| Control | Active comparator | Other: Thrust Manipulation (in weight bearing and non weight bearing)While Group B received manipulation in supine position by maitland's traditional thrust. Where the neck is slightly flexed by therapist hand on the occipit where therapist is standing behind the head. Neck is guided in right side flexion and opposite rotation and at the end of rang high velocity low amplitude thrust is applied. This was done for both sides if the cavitation sound was not heard manipulation was tried for a second time after 10 minutes by repositioning the patient but no more than two times in a day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Forward head posture
- Patients who had complain of neck pain
- Decrease range of flexion, extension, rotation and side flexion of cervical spine
- Craniovertebral angle below 48 were included
Key exclusion criteria (5 listed)
- Patients with structural or anatomical deformity,
- recent surgical history , degenerative changes ,
- cervical instability,
- malignancy
- radiculopathy
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 |
|---|---|---|
| Thrust Manipulation (in weight bearing and non weight bearing)Pain and Range of cervical motion was assessed before and after manipulation in both groups. | Other | Change in range of motion and within the weight bearing group, Control |
Primary outcome
Change in Neck pain before and after thrust manipulation
Time frame: As immediate effects are measured pain before giving manipulation and 10minutes after session is measured
pain will be calculated using Numeric pain rating scale(NPRS) before and after manipulation
Change in Cervical Range of motion before and after thrust manipulation
Time frame: As immediate effects are measured ranges of motion before giving manipulation and 10minutes after session is meas
Range Of Motion will be measured using inclinometer before and after manipulation
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 9 Mar 2023.
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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.
Maham Nasir, DPT principal investigator
Yusra institute of Rehabilitation sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrust Manipulation (in weight bearing and non weight bearing) in people with Cervical Pain, run by Yusra Medical and Dental College 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 4 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 9 Mar 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?
Change in Neck pain before and after thrust manipulation (time frame: As immediate effects are measured pain before giving manipulation and 10minutes after session is measured). The study lists 2 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 9 Mar 2023.