Low Back PainNCT06796465
McKenzie Protocol With/Without Postural Control Exercises on Pain, ROM, and Disability in Low Back Pain
A study testing Hot Pack in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic Low Back Pain (CLBP) is a prevalent global musculoskeletal disorder associated with significant physical, psychosocial, and economic burdens. The McKenzie method focuses on the use of sustained postures or repeated movements tailored to alleviate pain and restore function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Hot Pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Feb 2024to 10 Jan 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years
- Diagnosed with non-specific low back pain, with symptoms and pain persisting for over 3 months
- Individuals reporting a pain intensity of at least 4 out of 7 on the 11-point Numeric Pain Rating Scale (11-NPRS)
- Individuals scoring 4 or above on the Roland-Morris Questionnaire (RMQ) for low back pain
Who cannot join
- Pregnancy
- Chronic low back pain (LBP) due to trauma, structural issues, neurological symptoms, or radiating pain to the lower legs
- History of back surgery, spinal tumors, or infections
- Diagnosed neurological or musculoskeletal disorders unrelated to LBP, including, Stroke, Parkinson's disease, Demyelination disorders, Multiple sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mckenzie Protocol With and Without Progressive Postural Control Exercise on Pain, Range of Motion and Disability in Patients With Low Back Pain
Chronic Low Back Pain (CLBP) is a prevalent global musculoskeletal disorder associated with significant physical, psychosocial, and economic burdens. The McKenzie method focuses on the use of sustained postures or repeated movements tailored to alleviate pain and restore function. Progressive Postural Control Exercise (PPCE) is an innovative approach for managing CLBP. It combines elements of motor control exercises and resistance training, emphasizing challenges to postural control through phased progression to improve stability and function.
The aim of this study is to compare the effects of the McKenzie protocol, both with and without the integration of Progressive Postural Control Exercises (PPCE), on pain, range of motion, and disability in patients with low back pain.
Read more
This study utilized a randomized controlled design with two groups. Participants were recruited from Shaikh Zaid Hospital using non-probability convenience sampling. The intervention lasted six weeks, with assessments conducted at baseline, three weeks, and six weeks.
Group A received McKenzie exercises combined with Progressive Postural Control Exercises (PPCE), while Group B was treated with McKenzie exercises alone, without PPCE. Assessment tools included the Numeric Pain Rating Scale (NPRS) for pain, the Roland-Morris Disability Questionnaire (RMDQ) for disability, the Oswestry Disability Index (ODI) for disability, and an inclinometer for measuring range of motion.
- Conditions
- Low Back Pain
- Being tested
- McKenzie with Progressive Postural Control Exercises, McKenzie without Progressive Postural Control Exercises, Hot Pack
- Keywords
- Low back pain, McKenzie exercise, Progressive postural control exercise
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McKenzie with Progressive Postural Control ExercisesOther
Also called McKenzie, Progressive Postural Control
The McKenzie Exercises focus on progressive spinal extension to alleviate back pain. Key steps include Extension in Standing, where patients lean backward and return to a neutral stance; Extension in Lying (Partial Range), involving partial pushups in a prone position; and Extension in Lying (Full Range), where patients fully extend their arms to achieve maximum spinal extension. Each movement is held for 1-2 seconds.
The PPCE program enhances core strength and stability through three stages. In the First Stage (2 weeks), core muscles are trained against gravity using movements like pelvic retroversion, crunches, and glute bridges. The Second Stage (3 weeks) incorporates a Swiss ball to challenge trunk muscles with instability. In the Third Stage (3 weeks), a Swiss ball, stretch bands, and a 5 kg sandbag are used to increase complexity on unstable surfaces. Each stage includes six movements, lasting 5 minutes each, for a total session duration of 30 minutes.
McKenzie without Progressive Postural Control ExercisesOther
Subject were treated with McKenzie exercises without the addition of Progressive Postural Control Exercises (PPCE).The exercises included the following:
Standing Extension Exercises: Patients leaned backward from a balanced standing position, arching their back before returning to a neutral stance.
Extension in Lying (Partial Range): Performed in a prone position with hands placed under the shoulders, patients lifted their upper torso in a motion similar to a push-up.
Extension in Lying (Full Range): Similar to the partial range extension, but with fully extended arms, aiming for the maximum tolerated extension. Each movement was sustained for 1-2 seconds.
Hot PackDevice
for 10 to 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A received a combination of McKenzie exercises and Progressive Postural Control Exercises. Each session began with the application of hot packs for 10-15 minutes to prepare the patients for the exercises. Patients then performed three sets of three exercises, with 10 repetitions per set, lasting approximately 10-15 minutes in total. Receives: Other: McKenzie with Progressive Postural Control Exercises; Device: Hot Pack |
| Group B | Experimental | Group B was treated with McKenzie exercises without the integration of Progressive Postural Control Exercises. Each session began with the application of hot packs for 10-15 minutes to prepare the patients for the technique. Patients then performed three sets of three exercises, with 10 repetitions per set, lasting approximately 10-15 minutes in total. Receives: Other: McKenzie without Progressive Postural Control Exercises; Device: Hot Pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
The Numeric Pain Rating Scale (NPRS) will be used to assess patients' pain levels for chronic low back pain both before and after the exercises. This 11-point numeric scale ranges from 0, representing no pain (e.g., "no pain at all"), to 10, representing the worst pain imaginable (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS demonstrates strong validity, with values ranging from 0.86 to 0.96
Measured: Baseline, 3 and 6 weeks
The Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire (RMDQ) is a reliable and widely used tool for assessing disability in patients with low back pain. Its updated applications and adaptations have reinforced its validity across diverse patient populations and healthcare settings. The RMDQ consists of 24 items, with the total score calculated by summing the responses. A "yes" response is scored as 1, and a "no" response is scored as 0, resulting in a total score range of 0 to 24. This range reflects the level of disability, with higher scores indicating greater disability in individuals with low back pain.
Measured: Baseline, 3 and 6 weeks
Secondary outcomes (1)
Inclinometer
The inclinometer is a widely used tool in clinical and research settings for measuring the range of motion (ROM) in spinal, cervical, and limb assessments. It is particularly valuable in managing conditions such as thoracic kyphosis and general musculoskeletal dysfunction. The device demonstrates excellent reliability, with inter-rater correlation coefficients (ICC) around 0.96, indicating high agreement and consistency between different raters.
Measured: Baseline, 3 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start11 Feb 2024
- Primary completion2 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Humera Mubashar, MS OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796465
- Sponsor's protocol ID
- REC/RCR & AHS/24/0122
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Fan Z, Liu X, Zheng J, Zhang S, Zhang S, Yu Q, Lo WLA, Chen X, Wang C. Effect of Progressive Postural Control Exercise Versus Core Stability Exercise in Young Adults with Chronic Low Back Pain: A Randomized Controlled Trial. Pain Ther. 2023 Feb;12(1):293-308. doi: 10.1007/s40122-022-00458-x. Epub 2022 Dec 1.
PubMed 36454387
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mckenzie Protocol With and Without Progressive Postural Control Exercise on Pain, Range of Motion and Disability in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT06796465
- Acronym / sponsor ID
- REC/RCR & AHS/24/0122
- Conditions
- Low Back Pain
- Keywords
- Low back pain, McKenzie exercise, Progressive postural control exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Feb 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 28 Jan 2025 (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.
Chronic Low Back Pain (CLBP) is a prevalent global musculoskeletal disorder associated with significant physical, psychosocial, and economic burdens. The McKenzie method focuses on the use of sustained postures or repeated movements tailored to alleviate pain and restore function. Progressive Postural Control Exercise (PPCE) is an innovative approach for managing CLBP. It combines elements of motor control exercises and resistance training, emphasizing challenges to postural control through phased progression to improve stability and function.
The aim of this study is to compare the effects of the McKenzie protocol, both with and without the integration of Progressive Postural Control Exercises (PPCE), on pain, range of motion, and disability in patients with low back pain.
This study utilized a randomized controlled design with two groups. Participants were recruited from Shaikh Zaid Hospital using non-probability convenience sampling. The intervention lasted six weeks, with assessments conducted at baseline, three weeks, and six weeks.
Group A received McKenzie exercises combined with Progressive Postural Control Exercises (PPCE), while Group B was treated with McKenzie exercises alone, without PPCE. Assessment tools included the Numeric Pain Rating Scale (NPRS) for pain, the Roland-Morris Disability Questionnaire (RMDQ) for disability, the Oswestry Disability Index (ODI) for disability, and an inclinometer for measuring range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: McKenzie with Progressive Postural Control Exercises, Device: Hot PackGroup A received a combination of McKenzie exercises and Progressive Postural Control Exercises. Each session began with the application of hot packs for 10-15 minutes to prepare the patients for the exercises. Patients then performed three sets of three exercises, with 10 repetitions per set, lasting approximately 10-15 minutes in total. |
| Group B | Experimental | Other: McKenzie without Progressive Postural Control Exercises, Device: Hot PackGroup B was treated with McKenzie exercises without the integration of Progressive Postural Control Exercises. Each session began with the application of hot packs for 10-15 minutes to prepare the patients for the technique. Patients then performed three sets of three exercises, with 10 repetitions per set, lasting approximately 10-15 minutes in total. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-65 years
- Diagnosed with non-specific low back pain, with symptoms and pain persisting for over 3 months
- Individuals reporting a pain intensity of at least 4 out of 7 on the 11-point Numeric Pain Rating Scale (11-NPRS)
- Individuals scoring 4 or above on the Roland-Morris Questionnaire (RMQ) for low back pain
Key exclusion criteria (4 listed)
- Pregnancy
- Chronic low back pain (LBP) due to trauma, structural issues, neurological symptoms, or radiating pain to the lower legs
- History of back surgery, spinal tumors, or infections
- Diagnosed neurological or musculoskeletal disorders unrelated to LBP, including, Stroke, Parkinson's disease, Demyelination disorders, Multiple sclerosis
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 with Progressive Postural Control ExercisesAlso: McKenzie, Progressive Postural ControlThe McKenzie Exercises focus on progressive spinal extension to alleviate back pain. Key steps include Extension in Standing, where patients lean backward and return to a neutral stance; Extension in Lying (Partial Range), involving partial pushups in a prone position; and Extension in Lying (Full Range), where patients fully extend their arms to achieve maximum spinal extension. Each movement is held for 1-2 seconds. The PPCE program enhances core strength and stability through three stages. In the First Stage (2 weeks), core muscles are trained against gravity using movements like pelvic retroversion, crunches, and glute bridges. The Second Stage (3 weeks) incorporates a Swiss ball to challenge trunk muscles with instability. In the Third Stage (3 weeks), a Swiss ball, stretch bands, and a 5 kg sandbag are used to increase complexity on unstable surfaces. Each stage includes six movements, lasting 5 minutes each, for a total session duration of 30 minutes. | Other | Group A |
| McKenzie without Progressive Postural Control ExercisesSubject were treated with McKenzie exercises without the addition of Progressive Postural Control Exercises (PPCE).The exercises included the following: Standing Extension Exercises: Patients leaned backward from a balanced standing position, arching their back before returning to a neutral stance. Extension in Lying (Partial Range): Performed in a prone position with hands placed under the shoulders, patients lifted their upper torso in a motion similar to a push-up. Extension in Lying (Full Range): Similar to the partial range extension, but with fully extended arms, aiming for the maximum tolerated extension. Each movement was sustained for 1-2 seconds. | Other | Group B |
| Hot Packfor 10 to 15 minutes | Device | Group A, Group B |
Primary outcome
NPRS
Time frame: Baseline, 3 and 6 weeks
The Numeric Pain Rating Scale (NPRS) will be used to assess patients' pain levels for chronic low back pain both before and after the exercises. This 11-point numeric scale ranges from 0, representing no pain (e.g., "no pain at all"), to 10, representing the worst pain imaginable (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS demonstrates strong validity, with values ranging from 0.86 to 0.96
The Roland-Morris Disability Questionnaire
Time frame: Baseline, 3 and 6 weeks
The Roland-Morris Disability Questionnaire (RMDQ) is a reliable and widely used tool for assessing disability in patients with low back pain. Its updated applications and adaptations have reinforced its validity across diverse patient populations and healthcare settings. The RMDQ consists of 24 items, with the total score calculated by summing the responses. A "yes" response is scored as 1, and a "no" response is scored as 0, resulting in a total score range of 0 to 24. This range reflects the level of disability, with higher scores indicating greater disability in individuals with low back pain.
1 secondary outcome
Inclinometer
Time frame: Baseline, 3 and 6 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 28 Jan 2025.
- Background: PubMed 36454387Wang H, Fan Z, Liu X, Zheng J, Zhang S, Zhang S, Yu Q, Lo WLA, Chen X, Wang C. Effect of Progressive Postural Control Exercise Versus Core Stability Exercise in Young Adults with Chronic Low Back Pain: A Randomized Controlled Trial. Pain Ther. 2023 Feb;12(1):293-308. doi: 10.1007/s40122-022-00458-x. Epub 2022 Dec 1.
- 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.
Humera Mubashar, MS OMPT 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 Hot Pack in people with Low Back 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 4 inclusion and 4 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 28 Jan 2025. 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?
NPRS (time frame: Baseline, 3 and 6 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?
On the ClinicalTrials.gov record for NCT06796465, which also lists 1 linked publication.
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 28 Jan 2025.