Back PainNCT05207605
Effects of Rhythmic Stabilization and Mckenzie Techniques on Non Specific Chronic Low Back Pain
A study testing Rhythmic Stabilization (RS) and McKenzie technique in people with Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Non-specific low back pain is defined as low back pain not attributable to an identifiable, known specific pathology. Non-specific low back pain accounts for over 90% of patients presenting to primary care and these are the majority of the individuals with low back pain that present to physiotherapy.Objective of this… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Rhythmic Stabilization (RS) and McKenzie technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Dec 2021to 4 Jul 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- NSCLBP patients aged ≥ 18 to 45 years old(23).
- Both genders.
- Mild to moderate back pain with NPRS pain score value of between 2/10 - 6/10.
- Pain from at least past three months (12 weeks).
- No radiating pain below the gluteal fold.
Who cannot join
- Diagnosis of systemic metabolic and/or neurological disorder.
- Neuropathic pain.
- Any referred pain below gluteal fold or neurological involvement in lower limbs is not included.
- Pathological conditions or diagnosed with disk herniation, spinal stenosis, spondylolysthesis, and spondylitis and other medical illnesses such as tumor, kidney disease, and visceral disease that can be related with low back pain excluded in this study.
- Participants who had undergone surgery for LBP.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Rhythmic Stabilization and Mckenzie Techniques on Pain and Function in Patients With Non-specific Chronic Low Back Pain
Non-specific low back pain is defined as low back pain not attributable to an identifiable, known specific pathology. Non-specific low back pain accounts for over 90% of patients presenting to primary care and these are the majority of the individuals with low back pain that present to physiotherapy.Objective of this study is to compare the effects of rhythmic stabilization and McKenzie technique on pain and function in patients with non-specific chronic low back pain
Read the detailed description
Low back pain is the most common musculoskeletal condition worldwide. About 18% of the world's population suffers from low back pain and approximately 39% will suffer at least one episode of low back pain in their lifetime. Consequently, the costs associated with the treatment of patients with low back pain, absence from work , and disability are extremely high. The annual worldwide LBP incidence in adults to be 15% and the point prevalence to be 30% .A sedentary lifestyle with a lack of physical activity results in the loss of muscle power and strength and can be a predictor of LBP leading to recurrent LBP .In addition, a specific diagnosis of low back pain cannot be obtained in approximately 80% patients with low back pain, indicating that patients with low back pain are often diagnosed with nonspecific low back pain. Non-specific chronic low back pain (LBP) is a rather common and predominant health problem worldwide that affects people of all ages. Nonspecific low back pain is defined in the European guidelines for the management of chronic nonspecific low back pain (CNSLBP) as low back pain that is not attributable to a recognizable, specific pathology (e.g., infection, tumor, osteoporosis, fracture, structural deformity, and inflammatory diseases, such as ankylosing spondylitis, radicular syndrome, and cauda equina syndrome)Characteristic of chronic nonspecific low back pain are heavy pain, worsening with exertion and relieve with rest. In some cases the cause may be sprain or overstretch of a ligament or muscles. The endurance of trunk muscles is low in patients with low back pain as compared to individual without low back pain. The deep trunk muscles (Transverse Abdominis and Multifidus) responsible for maintaining the stability of spine. In other cases the cause may be a minor problem with the disc between two vertebrae or a minor problem with a small facet joint between two vertebrae. There may be other minor problems in the structures and tissues of the lower back that result in pain.The terminology becomes "chronic" low back pain when the symptom duration exceeds three months (nCLBP).Chronic low back pain (LBP) represents a significant healthcare problem that results in substantial costs to society .It is a prevalent condition that leads to increased disability and decreased quality of life.Non-specific LBP belongs to the group of musculoskeletal disorders, which include diverse conditions affecting muscles, bones, and/or joints of the limbs or the spine.
- Conditions
- Back Pain
- Being tested
- Rhythmic Stabilization (RS), McKenzie technique
- Keywords
- non specific low back pain, paraspinal muscles
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Stabilization (RS)Other
Group A includes rhythmic stabilization technique. The patient is in sitting position and faces the physical therapist. The RST program consisted of alternating (trunk flexion-extension) isometric contractions against resistance for 10 seconds, with no motion intended. Subjects performed 3 sets of 15 repetitions at maximal resistance provided by the same physical therapist. Rest intervals of 30 seconds and 60 seconds were provided after the completion of 15 repetitions for each pattern and between sets, respectively. The total duration of RS will be of approximately 33 minutes
McKenzie techniqueOther
McKenzie technique will be guided to conduct four extension exercises and three flexion exercisesAll flexion exercises will be repeated for ten repetitions for two sets. There are three minutes for resting intervals in every set. The McKenzie treatment will lasted for 20-40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic Stabilization (RS) | Experimental | The patient is in sitting position and faces the physical therapist. The RST program consisted of alternating (trunk flexion-extension) isometric contractions against resistance for 10 seconds, with no motion intended Receives: Other: Rhythmic Stabilization (RS) |
| McKenzie technique | Experimental | McKenzie exercises will be guided to conduct four extension exercises and three flexion exercises. Receives: Other: McKenzie technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NPRS)
Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in low back pain (LBP).The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
Measured: 4th week
Oswestery Disability Index
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. This scale contain question related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. For patients understanding, URDU version is used. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 %. Bed-bound
Measured: 4th week
Secondary outcomes (3)
ROM lumber spine (flexion)
The spinous process of the 1st sacral vertebra and the 12th thoracic vertebra will be considered as reference points for measuring the range of motion in bending forward
Measured: 4th week
ROM lumber spine (extension)
The spinous process of the 1st sacral vertebra and the 12th thoracic vertebra will be considered as reference points for measuring the range of motion in bending backward
Measured: 4th week
ROM lumber spine (side flexion)
The spinous process of the 12th thoracic vertebra was considered as reference point for measuring the range of motion of lumbar side flexion
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start2 Dec 2021
- Primary completion12 Jun 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Back 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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sana Hafeez, PhD*, Principal investigator, Riphah International University Lahore Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207605
- Sponsor's protocol ID
- REC/RCR & AHS/21/0121
- Status last verified
- Nov 2023
- First submitted
- 24 Jan 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luz Junior MAD, Almeida MO, Santos RS, Civile VT, Costa LOP. Effectiveness of Kinesio Taping in Patients With Chronic Nonspecific Low Back Pain: A Systematic Review With Meta-analysis. Spine (Phila Pa 1976). 2019 Jan 1;44(1):68-78. doi: 10.1097/BRS.0000000000002756.
PubMed 29952880Ganesan S, Acharya AS, Chauhan R, Acharya S. Prevalence and Risk Factors for Low Back Pain in 1,355 Young Adults: A Cross-Sectional Study. Asian Spine J. 2017 Aug;11(4):610-617. doi: 10.4184/asj.2017.11.4.610. Epub 2017 Aug 7.
PubMed 28874980Citko A, Gorski S, Marcinowicz L, Gorska A. Sedentary Lifestyle and Nonspecific Low Back Pain in Medical Personnel in North-East Poland. Biomed Res Int. 2018 Sep 9;2018:1965807. doi: 10.1155/2018/1965807. eCollection 2018.
PubMed 30271778Yang JH, Suk KS, Lee BH, Jung WC, Kang YM, Kim JH, Kim HS, Lee HM, Moon SH. Efficacy and Safety of Different Aceclofenac Treatments for Chronic Lower Back Pain: Prospective, Randomized, Single Center, Open-Label Clinical Trials. Yonsei Med J. 2017 May;58(3):637-643. doi: 10.3349/ymj.2017.58.3.637.
PubMed 28332372Iizuka Y, Iizuka H, Mieda T, Tsunoda D, Sasaki T, Tajika T, Yamamoto A, Takagishi K. Prevalence of Chronic Nonspecific Low Back Pain and Its Associated Factors among Middle-Aged and Elderly People: An Analysis Based on Data from a Musculoskeletal Examination in Japan. Asian Spine J. 2017 Dec;11(6):989-997. doi: 10.4184/asj.2017.11.6.989. Epub 2017 Dec 7.
PubMed 29279756Imamura M, Alfieri FM, Filippo TR, Battistella LR. Pressure pain thresholds in patients with chronic nonspecific low back pain. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):327-336. doi: 10.3233/BMR-150636.
PubMed 26406214
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhythmic Stabilization and Mckenzie Techniques on Pain and Function in Patients With Non-specific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05207605
- Acronym / sponsor ID
- REC/RCR & AHS/21/0121
- Conditions
- Back Pain
- Keywords
- non specific low back pain, paraspinal muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 26 Jan 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.
Non-specific low back pain is defined as low back pain not attributable to an identifiable, known specific pathology. Non-specific low back pain accounts for over 90% of patients presenting to primary care and these are the majority of the individuals with low back pain that present to physiotherapy.Objective of this study is to compare the effects of rhythmic stabilization and McKenzie technique on pain and function in patients with non-specific chronic low back pain
Detailed description
Low back pain is the most common musculoskeletal condition worldwide. About 18% of the world's population suffers from low back pain and approximately 39% will suffer at least one episode of low back pain in their lifetime. Consequently, the costs associated with the treatment of patients with low back pain, absence from work , and disability are extremely high. The annual worldwide LBP incidence in adults to be 15% and the point prevalence to be 30% .A sedentary lifestyle with a lack of physical activity results in the loss of muscle power and strength and can be a predictor of LBP leading to recurrent LBP .In addition, a specific diagnosis of low back pain cannot be obtained in approximately 80% patients with low back pain, indicating that patients with low back pain are often diagnosed with nonspecific low back pain. Non-specific chronic low back pain (LBP) is a rather common and predominant health problem worldwide that affects people of all ages. Nonspecific low back pain is defined in the European guidelines for the management of chronic nonspecific low back pain (CNSLBP) as low back pain that is not attributable to a recognizable, specific pathology (e.g., infection, tumor, osteoporosis, fracture, structural deformity, and inflammatory diseases, such as ankylosing spondylitis, radicular syndrome, and cauda equina syndrome)Characteristic of chronic nonspecific low back pain are heavy pain, worsening with exertion and relieve with rest. In some cases the cause may be sprain or overstretch of a ligament or muscles. The endurance of trunk muscles is low in patients with low back pain as compared to individual without low back pain. The deep trunk muscles (Transverse Abdominis and Multifidus) responsible for maintaining the stability of spine. In other cases the cause may be a minor problem with the disc between two vertebrae or a minor problem with a small facet joint between two vertebrae. There may be other minor problems in the structures and tissues of the lower back that result in pain.The terminology becomes "chronic" low back pain when the symptom duration exceeds three months (nCLBP).Chronic low back pain (LBP) represents a significant healthcare problem that results in substantial costs to society .It is a prevalent condition that leads to increased disability and decreased quality of life.Non-specific LBP belongs to the group of musculoskeletal disorders, which include diverse conditions affecting muscles, bones, and/or joints of the limbs or the spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythmic Stabilization (RS) | Experimental | Other: Rhythmic Stabilization (RS)The patient is in sitting position and faces the physical therapist. The RST program consisted of alternating (trunk flexion-extension) isometric contractions against resistance for 10 seconds, with no motion intended |
| McKenzie technique | Experimental | Other: McKenzie techniqueMcKenzie exercises will be guided to conduct four extension exercises and three flexion exercises. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- NSCLBP patients aged ≥ 18 to 45 years old(23).
- Both genders.
- Mild to moderate back pain with NPRS pain score value of between 2/10 - 6/10.
- Pain from at least past three months (12 weeks).
- No radiating pain below the gluteal fold.
Key exclusion criteria (5 listed)
- Diagnosis of systemic metabolic and/or neurological disorder.
- Neuropathic pain.
- Any referred pain below gluteal fold or neurological involvement in lower limbs is not included.
- Pathological conditions or diagnosed with disk herniation, spinal stenosis, spondylolysthesis, and spondylitis and other medical illnesses such as tumor, kidney disease, and visceral disease that can be related with low back pain excluded in this study.
- Participants who had undergone surgery for LBP.
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 |
|---|---|---|
| Rhythmic Stabilization (RS)Group A includes rhythmic stabilization technique. The patient is in sitting position and faces the physical therapist. The RST program consisted of alternating (trunk flexion-extension) isometric contractions against resistance for 10 seconds, with no motion intended. Subjects performed 3 sets of 15 repetitions at maximal resistance provided by the same physical therapist. Rest intervals of 30 seconds and 60 seconds were provided after the completion of 15 repetitions for each pattern and between sets, respectively. The total duration of RS will be of approximately 33 minutes | Other | Rhythmic Stabilization (RS) |
| McKenzie techniqueMcKenzie technique will be guided to conduct four extension exercises and three flexion exercisesAll flexion exercises will be repeated for ten repetitions for two sets. There are three minutes for resting intervals in every set. The McKenzie treatment will lasted for 20-40 minutes. | Other | McKenzie technique |
Primary outcome
Numerical Rating Scale (NPRS)
Time frame: 4th week
Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in low back pain (LBP).The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
Oswestery Disability Index
Time frame: 4th week
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. This scale contain question related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. For patients understanding, URDU version is used. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 %. Bed-bound
3 secondary outcomes
ROM lumber spine (flexion)
Time frame: 4th week
ROM lumber spine (extension)
Time frame: 4th week
ROM lumber spine (side flexion)
Time frame: 4th week
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 13 Nov 2023.
- Background: PubMed 29952880Luz Junior MAD, Almeida MO, Santos RS, Civile VT, Costa LOP. Effectiveness of Kinesio Taping in Patients With Chronic Nonspecific Low Back Pain: A Systematic Review With Meta-analysis. Spine (Phila Pa 1976). 2019 Jan 1;44(1):68-78. doi: 10.1097/BRS.0000000000002756.
- Background: PubMed 28874980Ganesan S, Acharya AS, Chauhan R, Acharya S. Prevalence and Risk Factors for Low Back Pain in 1,355 Young Adults: A Cross-Sectional Study. Asian Spine J. 2017 Aug;11(4):610-617. doi: 10.4184/asj.2017.11.4.610. Epub 2017 Aug 7.
- Background: PubMed 30271778Citko A, Gorski S, Marcinowicz L, Gorska A. Sedentary Lifestyle and Nonspecific Low Back Pain in Medical Personnel in North-East Poland. Biomed Res Int. 2018 Sep 9;2018:1965807. doi: 10.1155/2018/1965807. eCollection 2018.
- Background: PubMed 28332372Yang JH, Suk KS, Lee BH, Jung WC, Kang YM, Kim JH, Kim HS, Lee HM, Moon SH. Efficacy and Safety of Different Aceclofenac Treatments for Chronic Lower Back Pain: Prospective, Randomized, Single Center, Open-Label Clinical Trials. Yonsei Med J. 2017 May;58(3):637-643. doi: 10.3349/ymj.2017.58.3.637.
- Background: PubMed 29279756Iizuka Y, Iizuka H, Mieda T, Tsunoda D, Sasaki T, Tajika T, Yamamoto A, Takagishi K. Prevalence of Chronic Nonspecific Low Back Pain and Its Associated Factors among Middle-Aged and Elderly People: An Analysis Based on Data from a Musculoskeletal Examination in Japan. Asian Spine J. 2017 Dec;11(6):989-997. doi: 10.4184/asj.2017.11.6.989. Epub 2017 Dec 7.
- Background: PubMed 26406214Imamura M, Alfieri FM, Filippo TR, Battistella LR. Pressure pain thresholds in patients with chronic nonspecific low back pain. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):327-336. doi: 10.3233/BMR-150636.
- 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.
Sana Hafeez, PhD* principal investigator
Riphah International University Lahore Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Stabilization (RS) and McKenzie technique in people with 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 5 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 13 Nov 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?
Numerical Rating Scale (NPRS) (time frame: 4th week). 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 NCT05207605, which also lists 6 linked publications.
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 13 Nov 2023.