Mechanical Low Back PainNCT05522543
Comparison of Passive Translatoric Intervertebral Glides and Manual Segmental Traction
A study testing Conventional treatment with Passive translatoric intervertebral glides and Conventional treatment with manual segmental lumbar traction in people with Mechanical Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to find and compare the effects of passive translatoric intervertebral glides and manual segmental traction in patients with mechanical low back pain on pain ,range of motion and disability. Randomized controlled trial done at Aziz Bhatti Shaheed teaching hospital Gujrat. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Conventional treatment with Passive translatoric intervertebral glides and Conventional treatment with manual segmental lumbar traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Apr 2022to 25 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: Both Men and Women
- Age: 25 to 65 years
- Patients with mechanical low back pain and restricted lumbar movements for more than 3 months
- No neurological deficits
- No muscle weakness less than 4/5 during manual muscle testin
Who cannot join
- Pregnancy
- People with history of inflammatory MSK disorders like ankylosing spondylitis and Rheumatoid arthritis etc.
- Patient with neuromuscular disorders
- Other Musculoskeletal deformity
- Acute Trauma
- Malignancy
- Patients on medications for Cardiac failure
- Class III BMI
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Aziz Bhatti Shaheed teaching Hospital
Dhok Gujra, Punjab Province, 50700
About this study
Official title: Comparison of Passive Translatoric Intervertebral Glides and Manual Segmental Traction in Patients With Mechanical Low Back Pain
The aim of this study is to find and compare the effects of passive translatoric intervertebral glides and manual segmental traction in patients with mechanical low back pain on pain ,range of motion and disability. Randomized controlled trial done at Aziz Bhatti Shaheed teaching hospital Gujrat. Total 34 participants will be enrolled (17 in each group A and group B. Group A received PA glides while group B received manual traction 25-65 years participants were included in study. Study duration was of 3 months .Sampling technique applied was purposive non probability sampling technique. Tools used in the study are (NPRS),Modified Oswestry disability index. Data was analyzed through SPSS 22.
Read the detailed description
Low back pain is a global health issue and one of the leading causes of disability and morbidity worldwide. The overall lifetime prevalence of low back pain is estimated to be as high as 60%-84% .According to some studies low back pain is more common in women (60.9%)than in men (39.1%). In which 97% of the cases were reported to be of mechanical in origin. Mechanical back ache is the low back pain without any recognizable pathology. It can originate from spinal structures such as bone, joints, disc, and nervous or soft tissue. Mechanical back pain can be acute or chronic. Persistent pain for less than 4 to 6 weeks can be termed as acute mechanical low back pain or lumbago while pain lasting for more than 6 weeks is called chronic back pain. The episodes of disabling chronic low back pain has a tendency to reoccur and it affects up to 23% of the population globally with 24% to 84% of recurrence rate annually .
In a recent narrative article published by in 2020, current rehabilitation strategies available for low back pain were reviewed. Various approaches are patient advice, regular physical exercises, McKenzie method, lumbar stabilization exercises, directional preference exercises, Yoga, strength building and aerobic exercises, traditional Chinese practices including Tai-chi and Qigong exercises, spinal mobilization and manipulation, Traction, Hot and cold therapy, bracing and rest.
Joint mobilizations have been used for the treatment of musculoskeletal pain and to increase functionality for many years. The exact physiological mechanism by which intervertebral joint mobilizations reduce nociceptive activity in spinal lesion is still unknown but due to recent advancement in technology most of the researches believe it can be due to the stimulation of mechanoreceptors as well as free fluid movement within the joint space and disc structures .
In 1960s Maitland proposed a classification system for these joint mobilizations which is not only a treatment method but also a diagnostic tool that can be used to diagnose a joint dysfunction based on clinical findings.
A study in 2015 by Karina Yuko analyzed that use of Maitland's PA glides for 30 seconds in each painful lumbar vertebra twice a week for 4 weeks significantly increased strength and mobility and reduced pain after the 2nd week of intervention.
A study conducted in Pakistan by Komal et al in 2018 showed that Maitland's grade I and II spinal glides are effective in reducing pain in patients with chronic low backache and can be used as an effective treatment in low back pain management .
In 2018, a study published spinal mobilization and gliding techniques were found to be more effective in reducing pain than other active therapies including exercises (p<0.05) while these were not comparatively effective in reducing disability (p>0.05). When compared with manipulation technique, spinal manipulation was considered more effective than spinal mobilization and intervertebral glides in treating low back pain .
In 2017, conducted a systematic review with meta-analysis on lumbar stabilization exercises and conventional physical therapy along with manual therapeutic approaches for low back pain and concluded that no one form of exercise is more effective than the other in treating the pain or disability and encouraged using both forms of techniques in rehabilitation of musculoskeletal disorders .
While there are numerous treatment options available, one of the common practices used for treatment of low back pain is spinal traction. Spinal traction is a technique in which, depending on the mode of delivery, varying amount of force is used to separate the vertebrae. It provides pain relief by removing the pressure off the spinal structures as well as by neurophysiological effects such as pain modulation of nociceptive input. This is generally believed that traction benefits the patients with acute back pain with neurological deficits as well as spinal stiffness. Available evidences suggest that even a small dose of traction (5-10kg)or 10-20% of total body weight proves to be effective. While another study supports that the optimal force of traction should be 40% of the total body weight .Traction can be applied in various ways that include mechanical or motorized traction via pulley system, auto-traction without external help of the therapist, gravitational traction with a suspension device or a manual traction with force applied by therapist.
A cross sectional survey was conducted in 2015 to estimate the number of physical therapists who use traction in their clinical practices. 4000 physical therapists were randomly included in the study. The response rate was 25.5% from which 76.6% reported using traction. Most of those who used spinal traction in their practice preferred manual delivery methods (68.3%) while the others used mechanical traction tables along with other conventional physiotherapy interventions like posture correction or stabilizing exercises.
In 2020 a trial to report the immediate effects of lumbar traction in patients with chronic low back pain. A total 40% to 50% of the body weight for mechanical traction was used and the mode of delivery was intermittent traction with or without vibrations. The results showed that lumbar traction with the force of 40% of total body weight especially along with vibration can be an effective intervention in chronic low back pain.
As discussed earlier the causes of mechanical low back pain are vertebral joint degeneration, disc pathologies, spinal muscular imbalances or strains and nerve tissue irritation, therefore intervertebral translatoric glides and lumbar manual segmental traction can be effective for pain management and restricted joint mobility. While currently to our knowledge there exists very weak evidence to which one technique can proved to be more effective than the other. Therefore this study will evaluate the efficacy of both the interventions in pain, restricted range of motion and disability in patients with mechanical low back pain,
- Conditions
- Mechanical Low Back Pain
- Being tested
- Conventional treatment with Passive translatoric intervertebral glides, Conventional treatment with manual segmental lumbar traction
- Keywords
- Mechanical Low Back Pain,Mobilizations.Traction
- 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.
Conventional treatment with Passive translatoric intervertebral glidesOther
Patient education (Postural correction, lifting, sitting and sleeping positions) • Hot Pack 10 mins
- PA Glides (Central and Transverse mobilizations) (10 sec each) x5 sets • Core stabilization exercise (Knee to chest, bridges, prone press ups, cat and camel stretches) • Home plan (bridges, knee to chest, cat and camel stretch and prone press ups
Conventional treatment with manual segmental lumbar tractionOther
Patient education (Postural correction, lifting, sitting and sleeping positions) • Hot Pack 10 mins
- Manual lumbar Traction (L1-L5) for 15-20 sec x5 sets • Lumbar facet gapping (LFG) in side lying (10 sec 3 sets) and Lumbar rotational facet gapping (LRFG) in side lying (10 sec 3 sets) • .Core stability exercises (Knee to chest, bridges, prone press ups, cat and camel stretches) • Home plan
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment with manual segmental lumber traction | Experimental | Patient education (Postural correction, lifting, sitting and sleeping positions) • Hot Pack 10 mins
• Manual lumbar Traction (L1-L5) for 15-20 sec x5 sets • Lumbar facet gapping (LFG) in side lying (10 sec 3 sets) and Lumbar rotational facet gapping (LRFG) in side lying (10 sec 3 sets) • .Core stability exercises (Knee to chest, bridges, prone press ups, cat and camel stretches) • Home plan Receives: Other: Conventional treatment with Passive translatoric intervertebral glides |
| Conventional treatment with passive translatoric intervertebral glides | Active comparator | Patient education (Postural correction, lifting, sitting and sleeping positions) • Hot Pack 10 mins
• PA Glides (Central and Transverse mobilizations) (10 sec each) x5 sets • Core stabilization exercise (Knee to chest, bridges, prone press ups, cat and camel stretches) • Home plan (bridges, knee to chest, cat and camel stretch and prone press ups Receives: Other: Conventional treatment with manual segmental lumbar traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Oswestry disability Index( MODI)
MODI is a measure of disability that is a Gold standard tool for measuring functional outcome in low back pain. It is also used to discriminate between broad categories of back pain patients and it is useful to measure treatment outcomes. It is divided into ten sections that assess the level of pain and interference with physical activities such as sleeping, standing, walking, home making, social life and traveling. Each question has a possible six responses which are scored from 0 to 5. Patients check one response statement in each section that is most relevant to them. The score for each section is added and divided by the total possible score (fifty if all sections are completed), with the resulting score multiplied by a hundred to yield a percentage score with 0% equivalent to no disability and 100% equivalent to a great deal of disability.
Measured: Changes from the Baseline, at 2nd week and at 4th week.
Secondary outcomes (1)
NPRS 0 to 10
NPRS is the 11 point questionnaire that is used to assess the pain. The patient is instructed to choose a number from 0 to 10 that best describes their pain. 0 would mean "no pain" and 10 would mean "worst possible pain".
- 1 to 4: Mild pain
- 5 to 6: Moderate
- 7 to 10: severe The final rating will be the average of the 3 ratings taken during the last 24 hours.
Measured: Changes from the Baseline, at 2nd week and at 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start18 Apr 2022
- Primary completion5 Jun 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Low 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Affan Iqbal, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522543
- Sponsor's protocol ID
- REC/01049 Mahnoor
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 31 Aug 2022
- 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 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Passive Translatoric Intervertebral Glides and Manual Segmental Traction in Patients With Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT05522543
- Acronym / sponsor ID
- REC/01049 Mahnoor
- Conditions
- Mechanical Low Back Pain
- Keywords
- Mechanical Low Back Pain,Mobilizations.Traction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 31 Aug 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.
The aim of this study is to find and compare the effects of passive translatoric intervertebral glides and manual segmental traction in patients with mechanical low back pain on pain ,range of motion and disability. Randomized controlled trial done at Aziz Bhatti Shaheed teaching hospital Gujrat. Total 34 participants will be enrolled (17 in each group A and group B. Group A received PA glides while group B received manual traction 25-65 years participants were included in study. Study duration was of 3 months .Sampling technique applied was purposive non probability sampling technique. Tools used in the study are (NPRS),Modified Oswestry disability index. Data was analyzed through SPSS 22.
Detailed description
Low back pain is a global health issue and one of the leading causes of disability and morbidity worldwide. The overall lifetime prevalence of low back pain is estimated to be as high as 60%-84% .According to some studies low back pain is more common in women (60.9%)than in men (39.1%). In which 97% of the cases were reported to be of mechanical in origin. Mechanical back ache is the low back pain without any recognizable pathology. It can originate from spinal structures such as bone, joints, disc, and nervous or soft tissue. Mechanical back pain can be acute or chronic. Persistent pain for less than 4 to 6 weeks can be termed as acute mechanical low back pain or lumbago while pain lasting for more than 6 weeks is called chronic back pain. The episodes of disabling chronic low back pain has a tendency to reoccur and it affects up to 23% of the population globally with 24% to 84% of recurrence rate annually .
In a recent narrative article published by in 2020, current rehabilitation strategies available for low back pain were reviewed. Various approaches are patient advice, regular physical exercises, McKenzie method, lumbar stabilization exercises, directional preference exercises, Yoga, strength building and aerobic exercises, traditional Chinese practices including Tai-chi and Qigong exercises, spinal mobilization and manipulation, Traction, Hot and cold therapy, bracing and rest.
Joint mobilizations have been used for the treatment of musculoskeletal pain and to increase functionality for many years. The exact physiological mechanism by which intervertebral joint mobilizations reduce nociceptive activity in spinal lesion is still unknown but due to recent advancement in technology most of the researches believe it can be due to the stimulation of mechanoreceptors as well as free fluid movement within the joint space and disc structures .
In 1960s Maitland proposed a classification system for these joint mobilizations which is not only a treatment method but also a diagnostic tool that can be used to diagnose a joint dysfunction based on clinical findings.
A study in 2015 by Karina Yuko analyzed that use of Maitland's PA glides for 30 seconds in each painful lumbar vertebra twice a week for 4 weeks significantly increased strength and mobility and reduced pain after the 2nd week of intervention.
A study conducted in Pakistan by Komal et al in 2018 showed that Maitland's grade I and II spinal glides are effective in reducing pain in patients with chronic low backache and can be used as an effective treatment in low back pain management .
In 2018, a study published spinal mobilization and gliding techniques were found to be more effective in reducing pain than other active therapies including exercises (p<0.05) while these were not comparatively effective in reducing disability (p>0.05). When compared with manipulation technique, spinal manipulation was considered more effective than spinal mobilization and intervertebral glides in treating low back pain .
In 2017, conducted a systematic review with meta-analysis on lumbar stabilization exercises and conventional physical therapy along with manual therapeutic approaches for low back pain and concluded that no one form of exercise is more effective than the other in treating the pain or disability and encouraged using both forms of techniques in rehabilitation of musculoskeletal disorders .
While there are numerous treatment options available, one of the common practices used for treatment of low back pain is spinal traction. Spinal traction is a technique in which, depending on the mode of delivery, varying amount of force is used to separate the vertebrae. It provides pain relief by removing the pressure off the spinal structures as well as by neurophysiological effects such as pain modulation of nociceptive input. This is generally believed that traction benefits the patients with acute back pain with neurological deficits as well as spinal stiffness. Available evidences suggest that even a small dose of traction (5-10kg)or 10-20% of total body weight proves to be effective. While another study supports that the optimal force of traction should be 40% of the total body weight .Traction can be applied in various ways that include mechanical or motorized traction via pulley system, auto-traction without external help of the therapist, gravitational traction with a suspension device or a manual traction with force applied by therapist.
A cross sectional survey was conducted in 2015 to estimate the number of physical therapists who use traction in their clinical practices. 4000 physical therapists were randomly included in the study. The response rate was 25.5% from which 76.6% reported using traction. Most of those who used spinal traction in their practice preferred manual delivery methods (68.3%) while the others used mechanical traction tables along with other conventional physiotherapy interventions like posture correction or stabilizing exercises.
In 2020 a trial to report the immediate effects of lumbar traction in patients with chronic low back pain. A total 40% to 50% of the body weight for mechanical traction was used and the mode of delivery was intermittent traction with or without vibrations. The results showed that lumbar traction with the force of 40% of total body weight especially along with vibration can be an effective intervention in chronic low back pain.
As discussed earlier the causes of mechanical low back pain are vertebral joint degeneration, disc pathologies, spinal muscular imbalances or strains and nerve tissue irritation, therefore intervertebral translatoric glides and lumbar manual segmental traction can be effective for pain management and restricted joint mobility. While currently to our knowledge there exists very weak evidence to which one technique can proved to be more effective than the other. Therefore this study will evaluate the efficacy of both the interventions in pain, restricted range of motion and disability in patients with mechanical low back pain,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment with manual segmental lumber traction | Experimental | Other: Conventional treatment with Passive translatoric intervertebral glidesPatient education (Postural correction, lifting, sitting and sleeping positions) • Hot Pack 10 mins • Manual lumbar Traction (L1-L5) for 15-20 sec x5 sets • Lumbar facet gapping (LFG) in side lying (10 sec 3 sets) and Lumbar rotational facet gapping (LRFG) in side lying (10 sec 3 sets) • .Core stability exercises (Knee to chest, bridges, prone press ups, cat and camel stretches) • Home plan |
| Conventional treatment with passive translatoric intervertebral glides | Active comparator | Other: Conventional treatment with manual segmental lumbar tractionPatient education (Postural correction, lifting, sitting and sleeping positions) • Hot Pack 10 mins • PA Glides (Central and Transverse mobilizations) (10 sec each) x5 sets • Core stabilization exercise (Knee to chest, bridges, prone press ups, cat and camel stretches) • Home plan (bridges, knee to chest, cat and camel stretch and prone press ups |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gender: Both Men and Women
- Age: 25 to 65 years
- Patients with mechanical low back pain and restricted lumbar movements for more than 3 months
- No neurological deficits
- No muscle weakness less than 4/5 during manual muscle testin
Key exclusion criteria (8 listed)
- Pregnancy
- People with history of inflammatory MSK disorders like ankylosing spondylitis and Rheumatoid arthritis etc.
- Patient with neuromuscular disorders
- Other Musculoskeletal deformity
- Acute Trauma
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 |
|---|---|---|
| Conventional treatment with Passive translatoric intervertebral glidesPatient education (Postural correction, lifting, sitting and sleeping positions) • Hot Pack 10 mins • PA Glides (Central and Transverse mobilizations) (10 sec each) x5 sets • Core stabilization exercise (Knee to chest, bridges, prone press ups, cat and camel stretches) • Home plan (bridges, knee to chest, cat and camel stretch and prone press ups | Other | Conventional treatment with manual segmental lumber traction |
| Conventional treatment with manual segmental lumbar tractionPatient education (Postural correction, lifting, sitting and sleeping positions) • Hot Pack 10 mins • Manual lumbar Traction (L1-L5) for 15-20 sec x5 sets • Lumbar facet gapping (LFG) in side lying (10 sec 3 sets) and Lumbar rotational facet gapping (LRFG) in side lying (10 sec 3 sets) • .Core stability exercises (Knee to chest, bridges, prone press ups, cat and camel stretches) • Home plan | Other | Conventional treatment with passive translatoric intervertebral glides |
Primary outcome
Modified Oswestry disability Index( MODI)
Time frame: Changes from the Baseline, at 2nd week and at 4th week.
MODI is a measure of disability that is a Gold standard tool for measuring functional outcome in low back pain. It is also used to discriminate between broad categories of back pain patients and it is useful to measure treatment outcomes. It is divided into ten sections that assess the level of pain and interference with physical activities such as sleeping, standing, walking, home making, social life and traveling. Each question has a possible six responses which are scored from 0 to 5. Patients check one response statement in each section that is most relevant to them. The score for each section is added and divided by the total possible score (fifty if all sections are completed), with the resulting score multiplied by a hundred to yield a percentage score with 0% equivalent to no disability and 100% equivalent to a great deal of disability.
1 secondary outcome
NPRS 0 to 10
Time frame: Changes from the Baseline, at 2nd week and at 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 31 Aug 2022.
- 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 Affan Iqbal, PHD 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 Conventional treatment with Passive translatoric intervertebral glides and Conventional treatment with manual segmental lumbar traction in people with Mechanical 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 5 inclusion and 8 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 31 Aug 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?
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?
Modified Oswestry disability Index( MODI) (time frame: Changes from the Baseline, at 2nd week and at 4th week.). 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 31 Aug 2022.