NCT05522543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 4, 2022

Last Update Submit

August 30, 2022

Conditions

Keywords

Mechanical Low Back Pain,Mobilizations.Traction

Outcome Measures

Primary Outcomes (1)

  • 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.

    Changes from the Baseline, at 2nd week and at 4th week.

Secondary Outcomes (1)

  • NPRS 0 to 10

    Changes from the Baseline, at 2nd week and at 4th week.

Other Outcomes (1)

  • The joint range of motion assessed by Goniometer

    Changes from the Baseline, at 2nd week and at 4th week.

Study Arms (2)

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

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

Other: Conventional treatment with manual segmental lumbar traction

Interventions

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 lumber traction

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

Conventional treatment with passive translatoric intervertebral glides

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aziz Bhatti Shaheed teaching Hospital

Dhok Gujra, Punjab Province, 50700, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Affan Iqbal, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 31, 2022

Study Start

April 18, 2022

Primary Completion

June 5, 2022

Study Completion

July 25, 2022

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations