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Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain

Primary Purpose

Low Back Pain

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Manual pressure release
Dry needling
Heat therapy
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:- age between 30-60 pateint with subacute and chronic low back pain at least last 6 months. pateint with active MTrps. Exclusion Criteria: patient with fibromyalgia pregnant females patient with chronic diseases (osteoporosis, lungs disease and diabetes) patient with musculoskeletal injuries patient that are using any medication to relief pain like analgesic or muscle relaxants Any treatment for back pain in same period of research. patient having any radiculopathies or discogenic low back pain

Sites / Locations

  • Foundation University College of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling

manual pressure release

Arm Description

Total 12 sessions of trigger point dry needling at lumbar muscles with Hot pack,with 3 sessions per week

Hot pack for 15 min then manual pressure release

Outcomes

Primary Outcome Measures

pain intensity
visual analogue scale
functional disability
functional disability will be measured through oswestry disability index

Secondary Outcome Measures

Full Information

First Posted
December 26, 2022
Last Updated
December 26, 2022
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT05680493
Brief Title
Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain
Official Title
Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the effect of dry needling and manual pressure in patients having low back pain in terms of pain and disability. There will be two groups ; experimental and control. Half of study group will receive dry needling session along with hot pack. Half of study group will receive manual pressure technique along with hot pack.
Detailed Description
The study is Randomized Control Trail , which is being conducted in fauji foundation hospital and Foundation University College Of Rehabilitation (oct 2022-feb 2023) . Sample size of 50 individual was calculated using epitool with 95% confidence interval (CI), and power 80%. sample will be collected through pilot study . both groups will recieve conventional physiotherapy protocol (hot pack) Assessment will be done on baseline, and 4th week .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control trial which will consist of two groups, control and experimental
Masking
Participant
Masking Description
participants
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
Total 12 sessions of trigger point dry needling at lumbar muscles with Hot pack,with 3 sessions per week
Arm Title
manual pressure release
Arm Type
Active Comparator
Arm Description
Hot pack for 15 min then manual pressure release
Intervention Type
Procedure
Intervention Name(s)
Manual pressure release
Intervention Description
lengthens the muscle up to the increasing resistance, then gradually applies gentle pressure on MTrp until fingers feels a definite increase in tissue resistance (first barrier). Pressure would maintain until clinician sense relief of tension
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
A filiform needle is inserted at 45 degree in to trigger point and then twirl the needle up and down to release trigger point
Intervention Type
Procedure
Intervention Name(s)
Heat therapy
Intervention Description
Hydro collator pack will be placed on affected area for relaxation and pain relief for 15 min
Primary Outcome Measure Information:
Title
pain intensity
Description
visual analogue scale
Time Frame
4 weeks
Title
functional disability
Description
functional disability will be measured through oswestry disability index
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- age between 30-60 pateint with subacute and chronic low back pain at least last 6 months. pateint with active MTrps. Exclusion Criteria: patient with fibromyalgia pregnant females patient with chronic diseases (osteoporosis, lungs disease and diabetes) patient with musculoskeletal injuries patient that are using any medication to relief pain like analgesic or muscle relaxants Any treatment for back pain in same period of research. patient having any radiculopathies or discogenic low back pain
Facility Information:
Facility Name
Foundation University College of Physical Therapy
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

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Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain

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