Cupping Therapy in Chronic Nonspecific Low Back Pain

March 4, 2024 updated by: Iran University of Medical Sciences

Effectiveness of Cupping Therapy in Patients With Chronic Nonspecific Low Back Pain: a Randomized Sham-controlled Trial

Chronic non-specific low back pain is a common condition that can cause disability, physical and psychological impairment, limitations in daily activities, and participation restrictions. It also has significant economic and social impacts. Clinical guidelines recommend non-pharmacological interventions as the first-line treatment, including exercises, psychological therapies, and multidisciplinary rehabilitation. Pharmacological therapies are used when non-pharmacological approaches are not effective. Alternative therapies like cupping therapy have gained attention, but their efficacy is still debated due to limited high-quality studies. Further research is needed to determine the true benefits and effectiveness of cupping therapy in managing chronic low back pain. A recent study found that dry cupping therapy was not superior to sham cupping in improving pain, physical function, mobility, quality of life, psychological symptoms, or medication use in individuals with chronic non-specific low back pain. However, it's important to note that the study used dry cupping therapy in isolation, which may not reflect typical clinical practice. Well-designed clinical trials can provide a better understanding of the potential impact of cupping therapy on various aspects of chronic low back pain. Hence, the primary goal of this randomized clinical trial is to compare the effectiveness of true cupping therapy combined with routine physiotherapy versus sham cupping therapy combined with routine physiotherapy in patients suffering from chronic non-specific low back pain. The study aims to address the following key questions:

  • Does true dry cupping therapy, when combined with routine physiotherapy, provide greater improvement in pain and functional disability for patients with chronic non-specific low back pain?
  • Does true dry cupping therapy, when combined with routine physiotherapy, result in a higher improvement in quality of life for patients with chronic non-specific low back pain?

Participants in the intervention group will undergo 10 sessions of dry cupping therapy, with each session lasting 5 minutes and conducted three times per week. During the sessions, the therapist will move the cups longitudinally in upward-downward and downward-upward directions. In the control group, participants will assume the same positions as the intervention group, but two cups with small holes (<2mm in diameter) will be used to release negative pressure within seconds.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

RESEARCH OBJECTIVE:

The primary objective of this study is to examine the efficacy of true dry cupping therapy, in combination with routine physiotherapy, in comparison to sham dry cupping therapy, in combination with routine physiotherapy, for managing pain intensity and functional disability in individuals with chronic non-specific low back pain. The secondary objective is to evaluate the impact of 10 treatment sessions on the quality of life of patients with chronic non-specific low back pain.

RESEARCH DESIGN:

This study is a randomized, single-blind, sham-controlled trial conducted at two centers. The allocation ratio is 1:1, with a total of 80 participants with hypertrophic scar tissue. Random assignment to two groups of equal size will be done using the permuted block randomization method, utilizing four-letter blocks (A and B). The random treatment list will be placed in sealed and numbered envelopes, with letter A representing true dry cupping therapy and letter B representing sham dry cupping therapy. The random assignment process will be conducted by an individual outside the research team prior to the commencement of the study.

PROCEDURE:

At the beginning of the study, potential participants will undergo an assessment to determine their eligibility based on specific criteria. Once confirmed by an orthopedic surgeon, participants will be enrolled in the study. Eligible participants will be asked to complete an intake form, providing demographic data such as age, gender, height, weight, occupation, and information regarding major confounding variables like smoking and depression that may affect low back pain. Following that, participants will be requested to complete questionnaires assessing pain intensity, functional disability, and quality of life.

INTERVENTION:

After the baseline assessment, the principal investigator will administer dry cupping therapy to the intervention group consisting of 24 enrolled patients. The participants in this group will be asked to lie in a prone position, and the lumbar area between L1-L5 will be oiled. Two cups with a diameter of 4.5-5 cm will be placed bilaterally parallel to the lumbar spine vertebrae. The therapist will then perform dry cupping therapy by applying two suctions and moving the cups in an up-down and down-up direction for 5 minutes using both hands.

In contrast, the control group will assume the same positions as the intervention group, but the cups will be placed stationary for 5 minutes only. The cups in the control group will have small holes with a diameter of less than 2mm to release negative pressure within seconds. Double-sided tapes will be used to secure the cups and maintain contact with the skin.

Both groups will undergo routine physiotherapy, which includes a 20-minute session of transcutaneous electrical stimulation. The stimulation will be set at a frequency of 100 pulses per second and a duration of 60 microseconds. The intensity of the stimulation will be gradually adjusted until participants experience a sensory stimulus during the 20-minute session. Stabilization exercises such as abdominal hollowing and bridging exercises will also be included in the treatment.

The entire treatment duration will consist of 10 sessions, conducted three times per week.

REASSESSMENT:

After the interventions, measures of the primary and secondary outcomes will be collected immediately and two weeks after the final treatment session to evaluate the effectiveness of the cupping therapy intervention. Additionally, any adverse events following the cupping therapy procedures and adherence to the treatment will be assessed.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • 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 Contact

  • Name: Mohammadreza Pourahmadi, Ph.D. Postdoc research fellow
  • Phone Number: +989122245593
  • Email: pourahmadipt@gmail.com

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic non-specific low back pain lasting for a minimum of 3 months.
  • The pain intensity is rated between 3 and 6 on the visual analog scale.
  • The body mass index falls between 19 and 23.
  • No restrictions for therapeutic exercise and electrotherapy.

Exclusion Criteria:

  • The presence of comorbidities such as diabetes and cardiovascular problems.
  • The presence of spinal column deviations, such as scoliosis, is observed.
  • Signs of serious pathology of the spine (eg, fractures, inflammatory diseases, infection or tumours).
  • Consecutive absence of more than three sessions.
  • Patients' dissatisfaction with their participation in the study
  • Individuals who have been treated with cupping in the past.
  • Neurological, vestibular, visual or auditory deficits.
  • Currently performing physical therapy.
  • Irradiated lumbar or sacroiliac pain.
  • Fibromyalgia

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
Intervention / Treatment
Experimental: True dry cupping therapy
Participants in the true dry cupping therapy group, who have chronic non-specific low back pain, will receive a combination of dry cupping therapy and routine physiotherapy. During the dry cupping therapy sessions, two cups will be applied to the lumbar region and moved in an up-down and down-up direction.
Other: True dry cupping therapy
In the intervention group, participants will lie in a prone position, and the lumbar area between L1-L5 will be oiled. Two cups with a diameter of 4.5-5 cm will be placed bilaterally, parallel to the lumbar spine. The therapist will perform 5 minutes of dry cupping therapy, moving the cups up and down using both hands. Participants will also receive routine physiotherapy, including a 20-minute session of transcutaneous electrical stimulation with a frequency of 100 pulses per second and a duration of 60 microseconds. The stimulation intensity will be adjusted for sensory stimulus. Stabilization exercises like abdominal hollowing and bridging will be included. The treatment will consist of 10 sessions, three times per week.
Sham Comparator: Sham cupping therapy
Participants in the sham cupping therapy group, who have chronic non-specific low back pain, will undergo a combination of sham cupping therapy and routine physiotherapy. During the sham cupping therapy sessions, two cups with small holes will be placed stationary on the lumbar region.
Other: Sham cupping therapy
In the control group, participants will lie in a prone position, and the lumbar area between L1-L5 will be oiled. Two cups with a diameter of 4.5-5 cm will be placed bilaterally, parallel to the lumbar spine. However, unlike the intervention group, the cups in the control group will not be moved and will remain stationary for 5 minutes. The cups will have small holes (<2mm in diameter) to release negative pressure quickly. Double-sided tapes will be used to secure the cups and maintain contact with the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Change from baseline at 4-week and 6-week
The Numeric Pain Rating Scale (NPRS) will be utilized to assess changes in pain levels. This scale ranges from 0 to 100, with 0 representing no pain and 100 representing the maximum level of pain experienced by the patient. The NPRS has demonstrated responsiveness in measuring pain levels among individuals with low back pain.
Change from baseline at 4-week and 6-week
Functional disability
Time Frame: Change from baseline at 4-week and 6-week
The Persian version of the Oswestry Disability Index (ODI) will be employed to assess changes in functional disability. This questionnaire comprises 10 activities of daily living and yields a total score ranging from 0 to 100. A score below 25 indicates minimal disability, while scores between 25 and 50 represent moderate disability. Scores between 50 and 75 indicate severe disability, and scores between 75 and 100 reflect acute disability. The Persian version of this questionnaire has been previously validated and shown to be reliable in previous studies.
Change from baseline at 4-week and 6-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessment
Time Frame: Change from baseline at 4-week and 6-week
The self-reported quality of life based on the 36-Item Short-Form Health Survey (SF-36) will be assessed. This questionnaire consists of 36 items divided into 8 subscales: Physical Functioning, Role limitations due to physical problems, Bodily Pain, Vitality, General Health, Social Functioning, Role limitations due to emotional problems, and Mental Health. The scale ranges from 0 to 100. 0 denotes minimal quality of life and 100 denotes maximum quality of life.
Change from baseline at 4-week and 6-week

Collaborators and Investigators

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

Sponsor

Iran University of Medical Sciences

Investigators

  • Principal Investigator: Mohammadreza Pourahmadi, Iran University of Medical Sciences

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

Helpful Links

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

December 9, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.IUMS.REC.1401.455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Low Back Pain

Clinical Trials on True dry cupping therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe