NCT06751160

Brief Summary

The hamstring tightness is considered as the inability to achieve knee extension greater than 160 degrees while hip is flexed at 90 degrees. When low back pain (LBP) persists for 12 weeks or longer, it is termed as chronic low back pain. The objective of study is to see the effect of dry needling versus soft tissue mobilization on hamstring muscle on pain, range of motion and functionality in patients with chronic low back pain.

Trial Health

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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

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 20, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

Chronic Low Back PainDisabilityDry NeedlingHamstring TightnessSoft Tissue Mobilization

Outcome Measures

Primary Outcomes (4)

  • Numeric Pain Rating Scale

    Numeric Pain Rating Scale (NPRS) was used to measure low back pain. NPRS consists of 11 points, which range from 0= no pain, 1-4= mild pain, 4-7= moderate pain 7-10= severe pain . Researchers states that NPRS shows High test to re test reliability (ICC 0.96) in elderly populations with musculoskeletal disorders without having cognitive dysfunction.

    4 weeks

  • Oswestry Disability index (Urdu)

    The Oswestry Disability index (ODI) consists of 10 patient- completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).

    4 weeks

  • Inclinometer

    It was used to measure range of motion of low back. An instrument for measuring angles is an inclinometer. A sensor is housed in the housing of an inclinometer. The sensor measures the housing's tilt and is sensitive to gravity. After that, the angle is shown on a dial or digital display.

    4 weeks

  • Active Knee Extension Test

    The most effective way to exclude the hamstring muscle's extensibility range, with the hip fixed at a 90-degree angle and precise instrument placement, is to perform the active knee extension test. This technique provides accurate measures of hamstring length and extensibility when used in a supine 90/90 position. Both a normal goniometer and an electrogoniometer were used to measure the amount of extension. Whether hamstring tightness contributes to mechanical low back pain can be inferred from this result.

    4 Week

Study Arms (2)

Dry Needling

EXPERIMENTAL

Dry Needling along with baseline treatment

Other: Dry Needling

Soft Tissue Mobilization

EXPERIMENTAL

Soft Tissue Mobilization along with baseline treatment

Other: Soft Tissue Mobilization

Interventions

Baseline Treatment: Hot pack will be applied for 15 minutes on Hamstrings and lower back and transcutaneous electrical nerve stimulation (TENS) at lower back for warm up and pain relief to both groups. Then spinal mobilization (Poster lateral glide) of grade 1 and 2 (3 sets of 6 repetitions) i.e. within the spine resistance. Dry Needling will be given to group A along with baseline treatment through following protocol: Patient will be in prone lying. Sterilized disposable dry needles of 0.25\*60mm will be used. Dry needling will be performed on three points on Hamstring muscle for one minute each. We considered a line between ischial tuberosity and head of fibula to target long head of bicep femoris (60% of line) and short head of bicep femoris (30% of line). Semitendinosus and Semi Membranosus were targeted at a point of 60% of line from ischial tuberosity to medial epicondyl of femur. Sessions: Total 8 sessions will be given 2 sessions per week for 4 weeks.

Also known as: Group A
Dry Needling

Baseline Treatment: Hot pack will be applied for 15 minutes on Hamstrings and lower back and transcutaneous electrical nerve stimulation (TENS) at lower back for warm up and pain relief to both groups. Then spinal mobilization (Poster lateral glide) of grade 1 and 2 (3 sets of 6 repetitions) i.e. within the spine resistance. Soft Tissue Mobilization will be given to Group B along with Baseline treatment. Subject will be in prone lying position with knee bent at 30 to 60 degrees. Soft tissue mobilization will be applied on hamstring muscle through Graston technique. Massage cream will be applied on hamstring muscle and Graston Instrument will be rubbed from gluteal line to politeal fossa 30 times for 60 seconds. Sessions: Total 8 sessions will be given 2 sessions per week for 4 weeks.

Also known as: Group B
Soft Tissue Mobilization

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Reduction in active knee extension test \>25
  • Current back pain between 4 to 6 on Numeric Pain Rating scale
  • Low back pain for at least 12weeks0r 6 months

You may not qualify if:

  • Subjects using anticoagulants and having vascular diseases
  • Subjects with needle phobia and allergic to metals
  • Subjects with cognitive impairment
  • History of fracture in lumbar region
  • History of systemic diseases e.g. cancer or systemic joint pathologies
  • History of congestive heart failure in past 24 months
  • Subjects have used medications like narcotics or Muscle relaxants 30 days before enrolment into study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hameed Latif Medical Centre

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Ali Raza, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

December 20, 2024

First Posted

December 27, 2024

Study Start

July 15, 2024

Primary Completion

December 30, 2024

Study Completion

January 30, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations