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Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis

Primary Purpose

Myofascial Trigger Point Pain, Quadratus Lumborum Syndrome, Positional Fault of Pelvis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dry needling
Dry cupping
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain focused on measuring Dry needling, Dry cupping, Quadratus lumborum

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • On palpation the presence of at least 1 active trigger point in quadratus lumborum. So the patient presents with low back pain.
  • Patients presents with positional fault of pelvis (lateral tilt)(4).
  • Patients having chronic Low Back Pain for at least more than 6 months(3).
  • Patients agree to get treatment sessions for the research work.

Exclusion Criteria:

  • Participants should not have taken any medications like analgesics, anti-coagulants, Non-steroidal anti-inflammatory drugs or muscle relaxants during this study or even 3 days before this study.
  • Participants should not have received any other treatment for the pain management, because it will affect the results of the study.
  • Patients with bleeding disorders, local or systemic infection, acute muscle trauma.
  • Patients with comorbid conditions.
  • Patients with severe physical disability and true leg length discrepancy(1).
  • Pregnant females

Sites / Locations

  • Riphah IU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dry needling

Dry Cupping

Arm Description

Dry needling, hot pack, stretching exercises.

Dry cupping, hot pack, stretching exercises.

Outcomes

Primary Outcome Measures

Change in Pain by 'Pressure Pain Algometer'
Change in Pain from baseline was checked at 6th session by Pressure Pain Algometer. A follow up reading was also taken after 1 month for checking prolonged post treatment effects.
Change in Range of Motion of lumbar spine side flexion by 'Goniometer'
Change in ROM from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. A goniometer is a device that measures an angle or permits rotation of an object to a definite position

Secondary Outcome Measures

Change in pain by 'Numeric Pain Rating Scale'
Change in pain from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. The Numerical Pain Rating Scale (NPRS) is an 11 point pain scale that is completed by a patient himself, under the supervision of researcher.
Change in Range of Motion of lumbar side flexion by Measuring tape
Change in ROM from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. The method for using a tape measure to examine lateral flexion of the spine has been introduced in the literature.

Full Information

First Posted
January 10, 2021
Last Updated
August 27, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04719689
Brief Title
Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis
Official Title
Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis Due to Myofascial Trigger Points in Quadratus Lumborum
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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 project was a Randomized clinical trial conducted to Compare the effects of dry needling and dry cupping in Positional fault of pelvis due to Myofascial trigger points in Quadratus Lumborum so that we can have best treatment option for patients with myofascial trigger points.
Detailed Description
Non Probability Convenient sampling was done. Patients following eligibility criteria from Physiotherapy department of Islam Central hospital, Sialkot were considered. Sample size was calculated with Epitool calculator. 26 Participants were randomly allocated in two groups equally via convenient sampling method. Baseline assessment was done initially. Group A was given Dry needling technique and Group B was given Dry Cupping along with conventional physiotherapy treatment (hot pack and stretching). Duration of research was almost 6 months. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus Lumborum. All participants were provided written informed consent prior to commencement of the procedures. They were free to quit the treatment at any stage of research. Data was analyzed by using SPSS version 23.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain, Quadratus Lumborum Syndrome, Positional Fault of Pelvis, Myofascial Trigger Point in Quadratus Lumborum
Keywords
Dry needling, Dry cupping, Quadratus lumborum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
Dry needling, hot pack, stretching exercises.
Arm Title
Dry Cupping
Arm Type
Experimental
Arm Description
Dry cupping, hot pack, stretching exercises.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Experimental group 1 got this intervention containing Dry needling for 10 mins, followed by conventional physiotherapy treatment (hot pack and stretching) for 15 mins. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus lumborum
Intervention Type
Other
Intervention Name(s)
Dry cupping
Intervention Description
Experimental group 2 got this intervention containing Dry cupping for 10 mins, followed by conventional physiotherapy treatment (hot pack and stretching) for 15 mins. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus Lumborum
Primary Outcome Measure Information:
Title
Change in Pain by 'Pressure Pain Algometer'
Description
Change in Pain from baseline was checked at 6th session by Pressure Pain Algometer. A follow up reading was also taken after 1 month for checking prolonged post treatment effects.
Time Frame
Baseline, 6th session(at 3rd week), follow up session after 1 month
Title
Change in Range of Motion of lumbar spine side flexion by 'Goniometer'
Description
Change in ROM from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. A goniometer is a device that measures an angle or permits rotation of an object to a definite position
Time Frame
Baseline, 6th session(at 3rd week), follow up session after 1 month
Secondary Outcome Measure Information:
Title
Change in pain by 'Numeric Pain Rating Scale'
Description
Change in pain from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. The Numerical Pain Rating Scale (NPRS) is an 11 point pain scale that is completed by a patient himself, under the supervision of researcher.
Time Frame
Baseline, 6th session(at 3rd week), follow up session after 1 month
Title
Change in Range of Motion of lumbar side flexion by Measuring tape
Description
Change in ROM from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. The method for using a tape measure to examine lateral flexion of the spine has been introduced in the literature.
Time Frame
Baseline, 6th session(at 3rd week), follow up session after 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: On palpation the presence of at least 1 active trigger point in quadratus lumborum. So the patient presents with low back pain. Patients presents with positional fault of pelvis (lateral tilt)(4). Patients having chronic Low Back Pain for at least more than 6 months(3). Patients agree to get treatment sessions for the research work. Exclusion Criteria: Participants should not have taken any medications like analgesics, anti-coagulants, Non-steroidal anti-inflammatory drugs or muscle relaxants during this study or even 3 days before this study. Participants should not have received any other treatment for the pain management, because it will affect the results of the study. Patients with bleeding disorders, local or systemic infection, acute muscle trauma. Patients with comorbid conditions. Patients with severe physical disability and true leg length discrepancy(1). Pregnant females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah IU
City
Lahore
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26347305
Citation
Pavkovich R. EFFECTIVENESS OF DRY NEEDLING, STRETCHING, AND STRENGTHENING TO REDUCE PAIN AND IMPROVE FUNCTION IN SUBJECTS WITH CHRONIC LATERAL HIP AND THIGH PAIN: A RETROSPECTIVE CASE SERIES. Int J Sports Phys Ther. 2015 Aug;10(4):540-51.
Results Reference
background
PubMed Identifier
20823359
Citation
Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
Results Reference
background
PubMed Identifier
17893311
Citation
Haake M, Muller HH, Schade-Brittinger C, Basler HD, Schafer H, Maier C, Endres HG, Trampisch HJ, Molsberger A. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007 Sep 24;167(17):1892-8. doi: 10.1001/archinte.167.17.1892. Erratum In: Arch Intern Med. 2007 Oct 22;167(19):2072.
Results Reference
background
PubMed Identifier
15179160
Citation
Leetun DT, Ireland ML, Willson JD, Ballantyne BT, Davis IM. Core stability measures as risk factors for lower extremity injury in athletes. Med Sci Sports Exerc. 2004 Jun;36(6):926-34. doi: 10.1249/01.mss.0000128145.75199.c3.
Results Reference
background

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Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis

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