Nonspecific Chronic Low Back PainNCT05473416
Comparing the Effects of Pilates and McKenzie in Power Looms Workers Having Nonspecific Chronic Low Back Pain
A study testing McKenzie back extension exercise, Pilates pelvic tilt exercise and Baseline treatment in people with Nonspecific Chronic Low Back Pain and Pain, run by University of Faisalabad at 1 site in Pakistan.
Trial summary
to check the effects of Mckenzie intervention \& Pilates intervention on power looms workers having nonspecific chronic low back pain Read more about this study
- Who is it for?
- Ages 35 to 45 years, men only
- Conditions the study is for
- Nonspecific Chronic Low Back Pain, Pain, Disability Physical
- What is being tested?
- McKenzie back extension exercise, Pilates pelvic tilt exercise and Baseline treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2022to 24 Dec 2022
- 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 35 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age of the participants between 35-45 years.
- Only male workers diagnosed with nonspecific chronic low back pain.
- Power looms workers; Operator of power looms, working 12 hours per day.
- Low back pain for more than three months.
- Power looms workers with pain intensity on NPRS ranges from mild to moderate.
- Anterior pelvic tilt angle more than normal 13º±4.9º, anteriorly tilt to 18º to 25º.
Who cannot join
- Serious spinal pathology like tumors.
- Any inflammatory diseases.
- History of spinal surgery.
- Neurological disorder.
- Pain due to any systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effects of Pilates (Pelvic Tilt) and McKenzie Back Extension Exercises in Power Loom Workers Having Non-specific Chronic Low Back Pain
to check the effects of Mckenzie intervention \& Pilates intervention on power looms workers having nonspecific chronic low back pain
Read the detailed description
The purpose of this study is to check and compare the effects of McKenzie back extension exercise and Pilates pelvic tilt exercise on power looms workers having nonspecific chronic low back pain. To check the effects of these interventions on pain, disability, and anterior pelvic tilt angle.
In this study pain intensity of the subjects will be noted via a numeric pain rating scale. Pain will be measured at baseline, after 2 weeks and 4 weeks of intervention.
In this study disability of the patients will be measured via Quebec back pain disability scale. Disability will be measured at baseline, after 2 weeks and 4 weeks of intervention.
In this study, a goniometer will be used to measure the anterior pelvic tilt angle. Anterior pelvic tilt angle will be measured at baseline, after 2 weeks and 4 weeks of intervention.
- Conditions
- Nonspecific Chronic Low Back Pain, Pain, Disability Physical
- Being tested
- McKenzie back extension exercise, Pilates pelvic tilt exercise, Baseline treatment
- Keywords
- Pilates pelvic tilt exercise & McKenzie back exercise
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McKenzie back extension exerciseOther
McKenzie's back extension exercise consists; start with your belly facing down on the mat. Angle your legs in line with your hips, point your toes, and breathe into the next movement. Gently bending your elbows, push yourself up off the floor, until you feel the extension in your back. Be mindful not to lock your elbows as you support your weight with your hands and wrists for 10 seconds. Take deep inhales and exhales as you move in and out of the pose. Patients will be performed these activities under the supervision of physiotherapist.
Pilates pelvic tilt exerciseOther
Pilates pelvic tilt exercise consists; lie with your back on the floor in a neutral position with your legs bent and toes facing forward. Pull your belly button in toward your spine, pushing your pelvis up toward the ceiling. Tighten your gluteus and hip muscles as you tilt your pelvis forward. Hold for 10 seconds.
Baseline treatmentOther
Also called Postural guidelines + stretch break + rest
Postural guidelines + proper lifting technique + stretch break Rest
| Study group | Role | What they receive |
|---|---|---|
| 1- McKenzie (Group A) | Experimental | Back extension exercise. Total 10 repetitions in 1 set. Total 3 sets in a session. Total 3 sessions in a week. Total 12 sessions in a month. Receives: Other: McKenzie back extension exercise; Other: Baseline treatment |
| 2- Pilates (Group B) | Experimental | Pelvic tilt exercise Total 10 repetitions in 1 set. Total 3 sets in a session. Total 3 sessions in a week. Total 12 sessions in a month. Receives: Other: Pilates pelvic tilt exercise; Other: Baseline treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
In this study pain intensity of the subjects will be noted via numeric pain rating scale. The reading of NPRS is in number from 0 to 10 where 0 mean no pain, 10 means worst pain, 1-3 indicate mild pain, 4-6 present moderate pain, and 7-10 means severe pain. Patient tell us in numeric form how much he feels pain for example patient tell us he has 4 pain; its mean patient has moderate pain.
Measured: one month
Disability index
In this study disability of the patients will be measured via Quebec back pain disability scale. The 20-item Quebec back pain Disability Scale for Back Pain was created to measure degree of functional disability in people who have low back pain. The scale is a dependable and valid measurement used to evaluate each patient's improvement during treatment or rehabilitation programmers.
Measured: one month
Secondary outcomes (1)
Anterior pelvic tilt angle abnormailty
In this study goniometer was used to measure the anterior pelvic tilt angle of the power loom workers. Goniometer has three parts the body, stationary arm, and the mobile arm. To check the anterior pelvic tilt angle in subjects the body of the goniometer was placed on the anterior superior iliac spine horizontally, mobile arm was moved to the posterior superior iliac spine and noted the reading displayed on the goniometer.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start15 Aug 2022
- Primary completion13 Nov 2022
- Study completion24 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonspecific Chronic 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
- Model description
- The study was based on the research design of a randomized clinical trial. The single-blind study, in which participants were blind. The sample size of this study was 46. Patient was divided into 2 groups, 23 in each group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAFIZ MUHAMMAD ALMAS SABIR, University of Faisalabad
- Investigators
- Hafiz Muhammad Almas Sabir Muhammad Sabir Ali, MS OMPT, Principal investigator, The University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473416
- Sponsor's protocol ID
- HAFIZ MUHAMMAD ALMAS SABIR
- Status last verified
- Dec 2023
- First submitted
- 18 Jul 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Pilates (Pelvic Tilt) and McKenzie Back Extension Exercises in Power Loom Workers Having Non-specific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05473416
- Acronym / sponsor ID
- HAFIZ MUHAMMAD ALMAS SABIR
- Conditions
- Nonspecific Chronic Low Back Pain, Pain, Disability Physical
- Keywords
- Pilates pelvic tilt exercise & McKenzie back exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 13 Nov 2022 (actual)
- Study completion
- 24 Dec 2022 (actual)
- First posted
- 25 Jul 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 check the effects of Mckenzie intervention \& Pilates intervention on power looms workers having nonspecific chronic low back pain
Detailed description
The purpose of this study is to check and compare the effects of McKenzie back extension exercise and Pilates pelvic tilt exercise on power looms workers having nonspecific chronic low back pain. To check the effects of these interventions on pain, disability, and anterior pelvic tilt angle.
In this study pain intensity of the subjects will be noted via a numeric pain rating scale. Pain will be measured at baseline, after 2 weeks and 4 weeks of intervention.
In this study disability of the patients will be measured via Quebec back pain disability scale. Disability will be measured at baseline, after 2 weeks and 4 weeks of intervention.
In this study, a goniometer will be used to measure the anterior pelvic tilt angle. Anterior pelvic tilt angle will be measured at baseline, after 2 weeks and 4 weeks of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was based on the research design of a randomized clinical trial. The single-blind study, in which participants were blind. The sample size of this study was 46. Patient was divided into 2 groups, 23 in each group.
| Arm | Type | Receives |
|---|---|---|
| 1- McKenzie (Group A) | Experimental | Other: McKenzie back extension exercise, Other: Baseline treatmentBack extension exercise. Total 10 repetitions in 1 set. Total 3 sets in a session. Total 3 sessions in a week. Total 12 sessions in a month. |
| 2- Pilates (Group B) | Experimental | Other: Pilates pelvic tilt exercise, Other: Baseline treatmentPelvic tilt exercise Total 10 repetitions in 1 set. Total 3 sets in a session. Total 3 sessions in a week. Total 12 sessions in a month. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age of the participants between 35-45 years.
- Only male workers diagnosed with nonspecific chronic low back pain.
- Power looms workers; Operator of power looms, working 12 hours per day.
- Low back pain for more than three months.
- Power looms workers with pain intensity on NPRS ranges from mild to moderate.
Key exclusion criteria (5 listed)
- Serious spinal pathology like tumors.
- Any inflammatory diseases.
- History of spinal surgery.
- Neurological disorder.
- Pain due to any systemic diseases.
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 back extension exerciseMcKenzie's back extension exercise consists; start with your belly facing down on the mat. Angle your legs in line with your hips, point your toes, and breathe into the next movement. Gently bending your elbows, push yourself up off the floor, until you feel the extension in your back. Be mindful not to lock your elbows as you support your weight with your hands and wrists for 10 seconds. Take deep inhales and exhales as you move in and out of the pose. Patients will be performed these activities under the supervision of physiotherapist. | Other | 1- McKenzie (Group A) |
| Pilates pelvic tilt exercisePilates pelvic tilt exercise consists; lie with your back on the floor in a neutral position with your legs bent and toes facing forward. Pull your belly button in toward your spine, pushing your pelvis up toward the ceiling. Tighten your gluteus and hip muscles as you tilt your pelvis forward. Hold for 10 seconds. | Other | 2- Pilates (Group B) |
| Baseline treatmentAlso: Postural guidelines + stretch break + restPostural guidelines + proper lifting technique + stretch break Rest | Other | 1- McKenzie (Group A), 2- Pilates (Group B) |
Primary outcome
Pain intensity
Time frame: one month
In this study pain intensity of the subjects will be noted via numeric pain rating scale. The reading of NPRS is in number from 0 to 10 where 0 mean no pain, 10 means worst pain, 1-3 indicate mild pain, 4-6 present moderate pain, and 7-10 means severe pain. Patient tell us in numeric form how much he feels pain for example patient tell us he has 4 pain; its mean patient has moderate pain.
Disability index
Time frame: one month
In this study disability of the patients will be measured via Quebec back pain disability scale. The 20-item Quebec back pain Disability Scale for Back Pain was created to measure degree of functional disability in people who have low back pain. The scale is a dependable and valid measurement used to evaluate each patient's improvement during treatment or rehabilitation programmers.
1 secondary outcome
Anterior pelvic tilt angle abnormailty
Time frame: one month
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 5 Dec 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.
Hafiz Muhammad Almas Sabir Muhammad Sabir Ali, MS OMPT principal investigator
The University of Faisalabad
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 back extension exercise, Pilates pelvic tilt exercise and Baseline treatment in people with Nonspecific Chronic Low Back Pain and Pain, run by University of Faisalabad 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 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 5 Dec 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?
Pain intensity (time frame: one month). 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 5 Dec 2023.