Neck PainNCT05542875
Effects of Thrust Versus Non-Thrust Thoracic Manipulation on Mechanical Neck Pain.
A study testing Thrust Manipulation, Non-Thrust manipulation and Standard Treatment in people with Neck Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Neck pain ranks as the 4th leading cause of disability, with high prevalence of mechanical neck pain in young population. As high as 30% of %. Individuals suffering from neck often report difficulty in performance of daily life, absence from work and decreased productivity. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Thrust Manipulation, Non-Thrust manipulation and Standard Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 30 Jan 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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Age: 18-24 years
- Symptoms <30 days
- FABQPA score <12
- Increased upper thoracic spine kyphosis (visual estimate)
- CVA < 48 Degrees
Who cannot join
- Symptoms distal to shoulder
- Aggravation of symptoms with looking up
- Radiating lower back pain
- Neurological deficit
- Previous surgery
- Spondylolisthesis
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- Spinal stenosis
- Inflammatory disease
- Vertebrobasilar artery insufficiency
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
About this study
Neck pain ranks as the 4th leading cause of disability, with high prevalence of mechanical neck pain in young population. As high as 30% of %. Individuals suffering from neck often report difficulty in performance of daily life, absence from work and decreased productivity. Several manual therapy treatment approaches are used for mechanical neck pain. The focus of this study is to compare the effectiveness of thrust and non-thrust thoracic manipulation for the treatment of mechanical neck pain in young population
Read the detailed description
craniovertebral angle, cervical range of motion and pain will be noted for each participant.
- Conditions
- Neck Pain
- Being tested
- Thrust Manipulation, Non-Thrust manipulation, Standard Treatment
- 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 ManipulationProcedure or surgery
Prone thoracic extension manipulation technique will be applied from T2 - T6 to participants of Group A (Experimental group). Intervention will be applied on alternate days with a total of 4 treatment sessions
Non-Thrust manipulationProcedure or surgery
Maitland grade III or IV thoracic 0manipulation will be given to participants of Control group from T1 to T6. Posterior to anterior glide over spinous process will be maintained for 30 seconds. Intervention will be applied on alternate days with a total of 4 treatment sessions
Standard TreatmentProcedure or surgery
Standard treatment protocol includes moist heat, TENS and Post isometric relaxation technique. Standard treatment will be given to both groups on every session. Standard treatment consists of:
Superficial Moist Heat (Device): Superficial moist heat will me applied for 10 minutes on Upper Trapezius TENS (Device): TENS will be applied for 10 minutes at 80-100Hz, the electrodes will be placed at upper trapezius.
Post-isometric Relaxation (procedure/surgery): 5-10 repetions of Post Isometric relaxation technique will be applied on various muscle groups which include Upper trapezius, levator scapulae, sternocleidomastoid and scalenes.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Thrust Manipulation) | Experimental | Participants will be randomly allocated to Group A which will recieve Thrust manipulation treatment in addition to standard treatment protocol. Prone thoracic extension manipulation technique will be applied from T2 - T6 to participants for 4 sessions on alternate days Receives: Procedure: Thrust Manipulation; Procedure: Standard Treatment |
| Group B (Non-Thrust Manipulation) | Experimental | Participants will be randomly allocated to group B which, in addition to standard treatment protocol, will recieve Maitland grade III or IV manipulation from T1 to T6. Posterior to anterior glide over spinous process will be maintained for 30 seconds. Participants will recieve 4 sessions on alternate days Receives: Procedure: Non-Thrust manipulation; Procedure: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craniovertebral Angle
Craniovertebral Angle wll be measured using Goniometer. CVA >48 is considered normal, CVA <48 is considered as Forward head posture. Immovable arm of the goniometer will be placed at the C7 spinous process and the movable arm at the tragus of the ear making an angle between the two lines, normal of which is 49.9 and angle less than that is considered as abnormal. Data will be collected directly from participants using Gomiometer before initiation of treatment and after 4th session.
Measured: 8 days
Secondary outcomes (2)
Cervical Range of Motion
Cervical Range of motion will be measured using bubble inclinometer. Measurement will be taken before the initiation of treatment and after 4Th treatment session. Increase in Cervical ROM will be considered a positive outcome.
Measured: 8 days
Pain intensity
Pain will be assessed using Numeric pain rating scale which comprises of 11 points where point (0) signifies no pain and point (10) signifies worst imaginable pain. Measurement will be taken before the initiation of treatment and after 4Th treatment session. Low score for the NPRS will be considered a positive outcome.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Mar 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
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.
- 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
- Model description
- Randomized Controlled Trial Study
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542875
- Sponsor's protocol ID
- FUI/CTR/2022/15
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 16 Sep 2022
- 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 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thrust Versus Non-Thrust Thoracic Manipulation on Mechanical Neck Pain.
- ClinicalTrials.gov ID
- NCT05542875
- Acronym / sponsor ID
- FUI/CTR/2022/15
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 16 Sep 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.
Neck pain ranks as the 4th leading cause of disability, with high prevalence of mechanical neck pain in young population. As high as 30% of %. Individuals suffering from neck often report difficulty in performance of daily life, absence from work and decreased productivity. Several manual therapy treatment approaches are used for mechanical neck pain. The focus of this study is to compare the effectiveness of thrust and non-thrust thoracic manipulation for the treatment of mechanical neck pain in young population
Detailed description
craniovertebral angle, cervical range of motion and pain will be noted for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial Study
| Arm | Type | Receives |
|---|---|---|
| Group A (Thrust Manipulation) | Experimental | Procedure: Thrust Manipulation, Procedure: Standard TreatmentParticipants will be randomly allocated to Group A which will recieve Thrust manipulation treatment in addition to standard treatment protocol. Prone thoracic extension manipulation technique will be applied from T2 - T6 to participants for 4 sessions on alternate days |
| Group B (Non-Thrust Manipulation) | Experimental | Procedure: Non-Thrust manipulation, Procedure: Standard TreatmentParticipants will be randomly allocated to group B which, in addition to standard treatment protocol, will recieve Maitland grade III or IV manipulation from T1 to T6. Posterior to anterior glide over spinous process will be maintained for 30 seconds. Participants will recieve 4 sessions on alternate days |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both genders
- Age: 18-24 years
- Symptoms <30 days
- FABQPA score <12
- Increased upper thoracic spine kyphosis (visual estimate)
Key exclusion criteria (10 listed)
- Symptoms distal to shoulder
- Aggravation of symptoms with looking up
- Radiating lower back pain
- Neurological deficit
- Previous surgery
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 ManipulationProne thoracic extension manipulation technique will be applied from T2 - T6 to participants of Group A (Experimental group). Intervention will be applied on alternate days with a total of 4 treatment sessions | Procedure or surgery | Group A (Thrust Manipulation) |
| Non-Thrust manipulationMaitland grade III or IV thoracic 0manipulation will be given to participants of Control group from T1 to T6. Posterior to anterior glide over spinous process will be maintained for 30 seconds. Intervention will be applied on alternate days with a total of 4 treatment sessions | Procedure or surgery | Group B (Non-Thrust Manipulation) |
| Standard TreatmentStandard treatment protocol includes moist heat, TENS and Post isometric relaxation technique. Standard treatment will be given to both groups on every session. Standard treatment consists of: Superficial Moist Heat (Device): Superficial moist heat will me applied for 10 minutes on Upper Trapezius TENS (Device): TENS will be applied for 10 minutes at 80-100Hz, the electrodes will be placed at upper trapezius. Post-isometric Relaxation (procedure/surgery): 5-10 repetions of Post Isometric relaxation technique will be applied on various muscle groups which include Upper trapezius, levator scapulae, sternocleidomastoid and scalenes. | Procedure or surgery | Group A (Thrust Manipulation), Group B (Non-Thrust Manipulation) |
Primary outcome
Craniovertebral Angle
Time frame: 8 days
Craniovertebral Angle wll be measured using Goniometer. CVA >48 is considered normal, CVA <48 is considered as Forward head posture. Immovable arm of the goniometer will be placed at the C7 spinous process and the movable arm at the tragus of the ear making an angle between the two lines, normal of which is 49.9 and angle less than that is considered as abnormal. Data will be collected directly from participants using Gomiometer before initiation of treatment and after 4th session.
2 secondary outcomes
Cervical Range of Motion
Time frame: 8 days
Pain intensity
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Non-Thrust manipulation and Standard Treatment in people with Neck Pain, run by Foundation University Islamabad 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Sep 2022. 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?
Results are not available in the source record.
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?
Craniovertebral Angle (time frame: 8 days). 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 16 Sep 2022.