NCT05680493

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 11, 2023

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

December 26, 2022

Last Update Submit

December 26, 2022

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    visual analogue scale

    4 weeks

  • functional disability

    functional disability will be measured through oswestry disability index

    4 weeks

Study Arms (2)

Dry needling

EXPERIMENTAL

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

Procedure: Dry needlingProcedure: Heat therapy

manual pressure release

ACTIVE COMPARATOR

Hot pack for 15 min then manual pressure release

Procedure: Manual pressure releaseProcedure: Heat therapy

Interventions

Manual pressure releasePROCEDURE

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

manual pressure release
Dry needlingPROCEDURE

A filiform needle is inserted at 45 degree in to trigger point and then twirl the needle up and down to release trigger point

Dry needling
Heat therapyPROCEDURE

Hydro collator pack will be placed on affected area for relaxation and pain relief for 15 min

Dry needlingmanual pressure release

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 30-60
  • pateint with subacute and chronic low back pain at least last 6 months.
  • pateint with active MTrps.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry NeedlingDiathermy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesHyperthermia, Induced

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized control trial which will consist of two groups, control and experimental
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 11, 2023

Study Start

October 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

January 11, 2023

Record last verified: 2022-12

Locations

PA(1)