NCT05059249

Brief Summary

This study compared the effects of mechanical and manual traction on pain, disability and lumbar spinal curvature in patients with discogenic low back pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

September 17, 2021

Last Update Submit

September 17, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

    Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain.

    6 weeks

  • Oswestry disability index

    Changes from base line The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

    6 weeks

Study Arms (2)

Manual Traction

EXPERIMENTAL

Moist heat packs \& TENS for ten minutes followed by Manual Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient.

Procedure: Hot PackProcedure: Manual TractionProcedure: Joint MobilizationProcedure: TENS

Mechanical traction

EXPERIMENTAL

Moist heat packs \& TENS for ten minutes followed by Mechanical Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient

Procedure: Hot PackProcedure: Mechanical TractionProcedure: Joint MobilizationProcedure: TENS

Interventions

Hot PackPROCEDURE

Superficial Heating

Manual TractionMechanical traction

Manual Traction for 10 minutes

Manual Traction

Mechanical Traction for 10 minutes

Mechanical traction

3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions

Manual TractionMechanical traction
TENSPROCEDURE

TENS for 10 minutes with hot pack

Manual TractionMechanical traction

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with discogenic low back pain,
  • Patients of both genders
  • Age ranges from 20 to 60 years
  • NPRS \> 5

You may not qualify if:

  • Patients with non-mechanical back pain
  • Patients with known metabolic diseases,
  • Osteoporotic patients,
  • Recent history of spinal trauma or surgery,
  • Lumbar myelopathy,
  • Cauda equine syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, 46000, Pakistan

Location

MeSH Terms

Conditions

Low Back PainIntervertebral Disc DegenerationIntervertebral Disc DisplacementRadiculopathy

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Furqan Yaqoob, PhD*

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR
  • Muhammad Osama, PhD*

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 28, 2021

Study Start

March 1, 2019

Primary Completion

December 30, 2019

Study Completion

January 30, 2020

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations