Clinical trial NCT05522543: Comparison of Passive Translatoric Intervertebral Glides and Manual Segmental Traction
Official title: Comparison of Passive Translatoric Intervertebral Glides and Manual Segmental Traction in Patients With Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Low Back Pain
Keywords: Mechanical Low Back Pain,Mobilizations.Traction
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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,

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Modified Oswestry disability Index( MODI)
timeFrame: Changes from the Baseline, at 2nd week and at 4th week.
Secondary outcomes:
measure: NPRS 0 to 10
timeFrame: Changes from the Baseline, at 2nd week and at 4th week.
Other outcomes:
measure: The joint range of motion assessed by Goniometer
timeFrame: Changes from the Baseline, at 2nd week and at 4th week.
Locations:
city: Gujrāt
country: Pakistan
facility: Aziz Bhatti Shaheed teaching Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Affan Iqbal, PHD
role: PRINCIPAL_INVESTIGATOR
References: