Neck PainNCT05834114
Mckenzie and Rhythmical Stabilization Technique on Chronic Neck Pain
A study testing Mckenzie protocol and Rhythmic Stabilization technique in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be randomized clinical trial. Total 40 subjects will be assigned randomly by using non probability convenient into two groups. Group A will be given McKenzie protocol, with conventional physiotherapy treatment while Group B is Rhythmic stabilization group who will receive rhythmic stabilization, with… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Mckenzie protocol and Rhythmic Stabilization technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2023to 1 Aug 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 30-50
- Localized chronic neck pain for more than 3 months.
Who cannot join
- Participants suffering their neck pain was caused by any other complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mckenzie Protocol Versus Rhythmic Stabilization Technique on Pain, Range of Motion and Disability in Chronic Neck Pain.
The study will be randomized clinical trial. Total 40 subjects will be assigned randomly by using non probability convenient into two groups. Group A will be given McKenzie protocol, with conventional physiotherapy treatment while Group B is Rhythmic stabilization group who will receive rhythmic stabilization, with conventional physiotherapy. After confirmation of diagnosis with medical history and physical examination numeric pain rating scale (NPRS) and Neck disability index (NDI) would be used as an outcome measure tools for pain and disability respectively. Measure will be taken by goniometer. After data collection from defined study setting,data will be entered and analyzed at Riphah International University, Lahore.
Read the detailed description
Neck pain is a very common ailment that results in a great deal of suffering, impairment, and financial expense. The International Association for the Study of Pain is defined as Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by an unoriginally transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck. According to the study's findings, 69% of Balochistan University undergraduate students in Quetta, Pakistan, experienced neck pain. Pain in many cervical spine structures has the potential to become chronic neck pain. In epidemiologic research, pain is considered chronic if it lasts more than three months to six months, or five years.
McKenzie's treatment regimens were first used in Sweden in 1985 to address mechanical spine patient issues. For these kinds of patients, protocols were often employed in the 1990s. Repeated neck retraction exercises considerably lessen the pain and restore the cervical spine's lordosis curve in individuals with spinal pain.
Rhythmic Stabilization is characterized by isometric contractions against the resistance provided by the therapist, with the subject trying to maintain their position as the therapist changes the direction of resistance. Both techniques are effective in pain and range of motion in chronic neck pain.
McKenzie protocol and rhythmic stabilization are both studied individually before but their effects are not compared previously.
- Conditions
- Neck Pain
- Being tested
- Mckenzie protocol, Rhythmic Stabilization technique
- Keywords
- Mckenzie protocol, Rhythmic Stabilization technique
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mckenzie protocolOther
Also called McKenzie protocol for neck pain
In this group 20 participants will receive McKenzie protocol with conventional physical therapy. Participants will be asked to sit to treat extension deficit. The participant will be in a comfortable sitting position with a proper back support. Head is kept in forward facing without any up and done movement (10 to 15 times). Then, he restored the neutral sitting posture, and at the end of the range of motion (ROM), he' tuck in" chin by pushing the chin with his fingers (10 to 15 times). Subsequently, the participant will be requested to return to the original position while the therapist one hand's forefinger placed alongside the participant's mandible (to stabilize the head at full retraction position), and the heel of the other hand placed on the first or second dorsal vertebra (to provide posterior-anterior force). The exercises then repeated five or six times in a Session. the session will be of 45 mins, 3 session per week.
Rhythmic Stabilization techniqueOther
Also called Rhythmic Stabilization technique in neck pain
In this group participants will receive Rhythmic stabilization, with Conventional physiotherapy treatment the flexion , extension exercises performed. During flexion pattern the experimenter stood at the right side of patient and used his tip of fingers at chin. The experimenter then put his left hand at anterior side of head to apply resistance. then extension pattern is resisted and asked patient to match my resistance. The experimenter provided resistance against right rotation and lateral flexion provided during the exercise in order to induce strong muscle contractions. 3 sessions of 45 minutes a week, over a period of 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| McKenzie protocol | Experimental | In this group, 20 participants will be included. the interventions will be given for 15 mint. The exercises then repeated five or six times in a Session. the session will be of 45 mins, 3 session per week. Receives: Other: Mckenzie protocol |
| Rhythmic stabilization technique | Active comparator | In this group, 20 participants will be included. Rhythmic Stabilization with traditional physical therapy will be given for 3 sessions of 45 minutes a week, over a period of 10 weeks. Receives: Other: Rhythmic Stabilization technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale for pain
NPRS is based on 11-point numerical rating scale for determining pain intensity, 0(no pain) to 10(worst pain imaginable) pain intensity. On average over the past 2 day how bad has your pain been.
Measured: 3 weeks
Neck disability index
The Neck Disability Index (NDI) (modification of the Oswestry Low Back Pain Disability Index).
(0-8%) no disability, ( 10 - 28%) mild disability, (30-48% ) moderate disability, (50- 64%) severe disability, (70-100%) complete disability
Measured: 3 weeks
Secondary outcomes (1)
The Universal goniometer
It is used to measure ranges of neck flexion, extension, lateral rotation(right, left), Side bending (right, left)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Feb 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 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
- Model description
- blinding
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sanaullah, MS, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834114
- Sponsor's protocol ID
- REC/RCR & AHS/23/0108 Mustajab
- Status last verified
- Sep 2023
- First submitted
- 18 Apr 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- 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 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mckenzie Protocol Versus Rhythmic Stabilization Technique on Pain, Range of Motion and Disability in Chronic Neck Pain.
- ClinicalTrials.gov ID
- NCT05834114
- Acronym / sponsor ID
- REC/RCR & AHS/23/0108 Mustajab
- Conditions
- Neck Pain
- Keywords
- Mckenzie protocol, Rhythmic Stabilization technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 28 Apr 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.
The study will be randomized clinical trial. Total 40 subjects will be assigned randomly by using non probability convenient into two groups. Group A will be given McKenzie protocol, with conventional physiotherapy treatment while Group B is Rhythmic stabilization group who will receive rhythmic stabilization, with conventional physiotherapy. After confirmation of diagnosis with medical history and physical examination numeric pain rating scale (NPRS) and Neck disability index (NDI) would be used as an outcome measure tools for pain and disability respectively. Measure will be taken by goniometer. After data collection from defined study setting,data will be entered and analyzed at Riphah International University, Lahore.
Detailed description
Neck pain is a very common ailment that results in a great deal of suffering, impairment, and financial expense. The International Association for the Study of Pain is defined as Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by an unoriginally transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck. According to the study's findings, 69% of Balochistan University undergraduate students in Quetta, Pakistan, experienced neck pain. Pain in many cervical spine structures has the potential to become chronic neck pain. In epidemiologic research, pain is considered chronic if it lasts more than three months to six months, or five years.
McKenzie's treatment regimens were first used in Sweden in 1985 to address mechanical spine patient issues. For these kinds of patients, protocols were often employed in the 1990s. Repeated neck retraction exercises considerably lessen the pain and restore the cervical spine's lordosis curve in individuals with spinal pain.
Rhythmic Stabilization is characterized by isometric contractions against the resistance provided by the therapist, with the subject trying to maintain their position as the therapist changes the direction of resistance. Both techniques are effective in pain and range of motion in chronic neck pain.
McKenzie protocol and rhythmic stabilization are both studied individually before but their effects are not compared previously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- blinding
| Arm | Type | Receives |
|---|---|---|
| McKenzie protocol | Experimental | Other: Mckenzie protocolIn this group, 20 participants will be included. the interventions will be given for 15 mint. The exercises then repeated five or six times in a Session. the session will be of 45 mins, 3 session per week. |
| Rhythmic stabilization technique | Active comparator | Other: Rhythmic Stabilization techniqueIn this group, 20 participants will be included. Rhythmic Stabilization with traditional physical therapy will be given for 3 sessions of 45 minutes a week, over a period of 10 weeks. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 30-50
- Localized chronic neck pain for more than 3 months.
Key exclusion criteria (1 listed)
- Participants suffering their neck pain was caused by any other complications.
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 |
|---|---|---|
| Mckenzie protocolAlso: McKenzie protocol for neck painIn this group 20 participants will receive McKenzie protocol with conventional physical therapy. Participants will be asked to sit to treat extension deficit. The participant will be in a comfortable sitting position with a proper back support. Head is kept in forward facing without any up and done movement (10 to 15 times). Then, he restored the neutral sitting posture, and at the end of the range of motion (ROM), he' tuck in" chin by pushing the chin with his fingers (10 to 15 times). Subsequently, the participant will be requested to return to the original position while the therapist one hand's forefinger placed alongside the participant's mandible (to stabilize the head at full retraction position), and the heel of the other hand placed on the first or second dorsal vertebra (to provide posterior-anterior force). The exercises then repeated five or six times in a Session. the session will be of 45 mins, 3 session per week. | Other | McKenzie protocol |
| Rhythmic Stabilization techniqueAlso: Rhythmic Stabilization technique in neck painIn this group participants will receive Rhythmic stabilization, with Conventional physiotherapy treatment the flexion , extension exercises performed. During flexion pattern the experimenter stood at the right side of patient and used his tip of fingers at chin. The experimenter then put his left hand at anterior side of head to apply resistance. then extension pattern is resisted and asked patient to match my resistance. The experimenter provided resistance against right rotation and lateral flexion provided during the exercise in order to induce strong muscle contractions. 3 sessions of 45 minutes a week, over a period of 10 weeks. | Other | Rhythmic stabilization technique |
Primary outcome
Numeric pain rating scale for pain
Time frame: 3 weeks
NPRS is based on 11-point numerical rating scale for determining pain intensity, 0(no pain) to 10(worst pain imaginable) pain intensity. On average over the past 2 day how bad has your pain been.
Neck disability index
Time frame: 3 weeks
The Neck Disability Index (NDI) (modification of the Oswestry Low Back Pain Disability Index). (0-8%) no disability, ( 10 - 28%) mild disability, (30-48% ) moderate disability, (50- 64%) severe disability, (70-100%) complete disability
1 secondary outcome
The Universal goniometer
Time frame: 3 weeks
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 25 Sep 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.
Muhammad Sanaullah, MS principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mckenzie protocol and Rhythmic Stabilization technique 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 2 inclusion and 1 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 25 Sep 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 for pain (time frame: 3 weeks). 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 25 Sep 2023.