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Chronic Low-back PainNCT06193603

Cupping Therapy in Chronic Nonspecific Low Back Pain

A study testing True dry cupping therapy in people with Chronic Low-back Pain and Chronic Non-specific Low Back Pain, run by Iran University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 years
What is being tested?
True dry cupping therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteIran
Study dates
1 Oct 2024to 1 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • Neurological, vestibular, visual or auditory deficits.
  • Currently performing physical therapy.
  • Irradiated lumbar or sacroiliac pain.
  • Fibromyalgia

Trial locations and contacts

1 site in 1 country.

Iran1 site
  • Iran University of Medical Sciences

    Tehran, Tehran Province

Other trials in Iran

About this study

Official title: 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.

Read the 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.

Being tested
True dry cupping therapy, Sham cupping therapy
Keywords
Chronic non-specific low back pain, Cupping therapy, Randomized sham-controlled trial
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • True dry cupping therapyOther

    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 cupping therapyOther

    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.

Study groups in NCT06193603
Study groupRoleWhat they receive
True dry cupping therapyExperimentalParticipants 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.
Receives: Other: True dry cupping therapy
Sham cupping therapySham comparatorParticipants 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.
Receives: Other: Sham cupping therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline at 4-week and 6-week

  2. 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.

    Measured: Change from baseline at 4-week and 6-week

Secondary outcomes (1)
  1. Quality of life assessment

    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.

    Measured: Change from baseline at 4-week and 6-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start1 Oct 2024
  3. Primary completion1 Apr 2025
  4. Study completion1 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06193603
Sponsor's protocol ID
IR.IUMS.REC.1401.455
Status last verified
Aug 2025
First submitted
9 Dec 2023
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33757719
  • 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.

    PubMed 31871257
  • 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.

    PubMed 30462793
  • 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.

    PubMed 23886511
  • 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.

    PubMed 37965178
  • 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.

    PubMed 31760207
  • 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.

    PubMed 29609566
  • 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.

    PubMed 35770601

Questions about this trial

What is this clinical trial studying?

A study testing True dry cupping therapy in people with Chronic Low-back Pain and Chronic Non-specific Low Back Pain, run by Iran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (time frame: Change from baseline at 4-week and 6-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06193603, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.

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