Cupping Therapy in Chronic Nonspecific Low Back Pain

NCT06193603 | Completed DMC

• 1 other identifier: IR.IUMS.REC.1401.455
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain; Chronic Non-specific Low Back Pain; Low Back Pain; Cupping Therapy

Keywords

Chronic non-specific low back pain; Cupping therapy; Randomized sham-controlled trial

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  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

  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 Outcomes (1)

• Quality of life assessment

  Change from baseline at 4-week and 6-week

Study Arms (2)

True dry cupping therapy

EXPERIMENTAL

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

Sham cupping therapy

SHAM COMPARATOR

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

Interventions

True dry cupping therapy OTHER

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.

True dry cupping therapy

Sham cupping therapy OTHER

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.

Sham cupping therapy

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

Study Sites (1)

Iran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

Related Publications (8)

• Almeida Silva HJ, Barbosa GM, Scattone Silva R, Saragiotto BT, Oliveira JMP, Pinheiro YT, Lins CAA, de Souza MC. Dry cupping therapy is not superior to sham cupping to improve clinical outcomes in people with non-specific chronic low back pain: a randomised trial. J Physiother. 2021 Apr;67(2):132-139. doi: 10.1016/j.jphys.2021.02.013. Epub 2021 Mar 20.

  PMID: 33757719 BACKGROUND

• Silva HJA, Saragiotto BT, Silva RS, Lins CAA, de Souza MC. Dry cupping in the treatment of individuals with non-specific chronic low back pain: a protocol for a placebo-controlled, randomised, double-blind study. BMJ Open. 2019 Dec 22;9(12):e032416. doi: 10.1136/bmjopen-2019-032416.

  PMID: 31871257 BACKGROUND

• Moura CC, Chaves ECL, Cardoso ACLR, Nogueira DA, Correa HP, Chianca TCM. Cupping therapy and chronic back pain: systematic review and meta-analysis. Rev Lat Am Enfermagem. 2018 Nov 14;26:e3094. doi: 10.1590/1518-8345.2888.3094.

  PMID: 30462793 BACKGROUND

• Huang CY, Choong MY, Li TS. Effectiveness of cupping therapy for low back pain: a systematic review. Acupunct Med. 2013 Sep;31(3):336-7. doi: 10.1136/acupmed-2013-010385. Epub 2013 Jul 25. No abstract available.

  PMID: 23886511 BACKGROUND

• Wang L, Cai Z, Li X, Zhu A. Efficacy of cupping therapy on pain outcomes: an evidence-mapping study. Front Neurol. 2023 Oct 26;14:1266712. doi: 10.3389/fneur.2023.1266712. eCollection 2023.

  PMID: 37965178 BACKGROUND

• Volpato MP, Breda ICA, de Carvalho RC, de Castro Moura C, Ferreira LL, Silva ML, Silva JRT. Single Cupping Thearpy Session Improves Pain, Sleep, and Disability in Patients with Nonspecific Chronic Low Back Pain. J Acupunct Meridian Stud. 2020 Apr;13(2):48-52. doi: 10.1016/j.jams.2019.11.004. Epub 2019 Nov 21.

  PMID: 31760207 BACKGROUND

• Teut M, Ullmann A, Ortiz M, Rotter G, Binting S, Cree M, Lotz F, Roll S, Brinkhaus B. Pulsatile dry cupping in chronic low back pain - a randomized three-armed controlled clinical trial. BMC Complement Altern Med. 2018 Apr 2;18(1):115. doi: 10.1186/s12906-018-2187-8.

  PMID: 29609566 BACKGROUND

• Salemi MM, Gomes VMDSA, Bezerra LMR, Melo TMS, Alencar GG, Montenegro IHPM, Calado APM, Montenegro EJN, Siqueira GR. Effect of Dry Cupping Therapy on Pain and Functional Disability in Persistent Non-Specific Low Back Pain: A Randomized Controlled Clinical Trial. J Acupunct Meridian Stud. 2021 Dec 31;14(6):219-230. doi: 10.51507/j.jams.2021.14.6.219.

  PMID: 35770601 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammadreza Pourahmadi

  Iran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant) Participants in the control group will undergo a similar procedure to those in the intervention group. Two cups will be placed on the lumbar region, but the sham cups will have small holes (\<2mm in diameter) to release negative pressure quickly. Additionally, to reduce bias, the data analyst will be blinded to the group assignments of the participants. Each participant will be identified by a unique numerical code to maintain anonymity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: January 5, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

IR (1)