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

August 27, 2021 updated by: Riphah International University

Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis Due to Myofascial Trigger Points in Quadratus Lumborum

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54000
        • Riphah IU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dry needling
Dry needling, hot pack, stretching exercises.
Other: Dry needling
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
Experimental: Dry Cupping
Dry cupping, hot pack, stretching exercises.
Other: Dry cupping
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pain by 'Pressure Pain Algometer'
Time Frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
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.
Baseline, 6th session(at 3rd week), follow up session after 1 month
Change in Range of Motion of lumbar spine side flexion by 'Goniometer'
Time Frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
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
Baseline, 6th session(at 3rd week), follow up session after 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pain by 'Numeric Pain Rating Scale'
Time Frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
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.
Baseline, 6th session(at 3rd week), follow up session after 1 month
Change in Range of Motion of lumbar side flexion by Measuring tape
Time Frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
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.
Baseline, 6th session(at 3rd week), follow up session after 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/Lhr/20/0101 Huma Akhtar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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