Cervical SpondylosisCTNCT06271525
Effect of Cupping Therapy on Nitric Oxide Level in Patients With Cervical Spondylosis
A study testing cupping therapy in people with Cervical Spondylosis, run by Shady Abdelsattar Refaat.
Trial summary
this study will be conducted to investigate the effect of cupping therapy on the nitric oxide level in patients with cervical spondylosis Read more about this study
- Who is it for?
- Ages 24 to 65 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- cupping therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2024to 20 May 2024
- 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 24 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with (cervical spondylosis) from both sexes.
- Age range (24-60) in chronic stages.
- BMI from20-25 kg/m2.
Who cannot join
- Renal and hepatic patients.
- Anemia, hepatic disease, and dermatological diseases.
- Morbid obese patients if their BMI exceeds the 25 kg/m2 will be also excluded.
- the patients are taking any medications known to affect the pain level
- The patients have a systemic illness, dermatological problems, skin allergy, local ischemic problems
About this study
this study will be conducted to investigate the effect of cupping therapy on the nitric oxide level in patients with cervical spondylosis
Read the detailed description
Cupping therapy is one of the oldest alternative medical procedures, along with acupuncture, with more than 3500 years of history to treat pain and various disorders. Cupping induces various biological responses that could be evoked by suction of the skin, About 5 to 10 minutes of cupping causes extravascular blood within the subcutaneous tissue and creates bruise-like marks. Therefore, cupping induces mild damage to a painful part of the body and accelerates healing by evoking the natural healing process. While this hypothesis is acceptable for some people, it might not be enough to change the minds of skeptics since cupping itself has no curative effects. Suppose the healing process after cupping can be accelerated by merging cupping with scientifically proven techniques. In that case, this new form of therapy might help to persuade skeptics of the efficacy of cupping. Integrative medicine, including acupuncture, dry needling, and cupping, is being used increasingly in the United States. evidence regarding their efficacy in the management of musculoskeletal conditions is heterogeneous and subject to several limitations. despite these limitations, acupuncture consistently is more effective than no treatment and is relatively safe. for chronic back pain, it is recommended as a first-line noninvasive therapy. for neck pain, acupuncture provides benefits when it is combined with other treatments. dry needling is similar to acupuncture and frequently is regarded as a form of acupuncture. sixty patients with cervical spondylosis will receive cupping therapy for three months.
- Conditions
- Cervical Spondylosis
- Being tested
- cupping therapy
- Keywords
- cupping therapy, Cervical Spondylosis
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cupping therapyOther
All the patients will be asked to be in a sitting position with both feet flat on the floor the cupping group will receive the cupping bloodletting at three acupuncture points (SI15, GB21, LI15) the medium size glass with a diameter of 4cm and a volume of 260ml. Each wet cupping treatment procedure will last about 20 min and will be conducted in five steps.
- -Primary sucking
- -Scarification 3- Bloodletting 4-Removal
5 -Dressing
| Study group | Role | What they receive |
|---|---|---|
| cupping therapy | Experimental | patients with cervical spondylosis will receive cupping therapy one time per month for three months Receives: Other: cupping therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the nitric oxide level
Spectrophotometer device will be used to measure the level of nitric oxide
Measured: up to three months
Secondary outcomes (2)
cervical range of motion
electrogoniomter device will be used to assess cervical range of motion
Measured: up to three months
pain intensity
visual analogue scale will be used to measure pain intensity. The VAS is a 100-mm horizontal line that may be used to quantify symptoms in a continuous fashion. It is easy to use and requires very little written language. Patients are instructed to indicate the intensity of their pain by marking on a line anchored by "no pain" on the left and "worst imaginable pain" on the right.
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- cupping therapy
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shady Abdelsattar Refaat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shady Abdelsattar Refaat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271525
- Sponsor's protocol ID
- P.T.REC/012/002532
- Acronym
- CT
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cupping Therapy on Nitric Oxide Level in Patients With Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT06271525
- Acronym / sponsor ID
- CT / P.T.REC/012/002532
- Conditions
- Cervical Spondylosis
- Keywords
- cupping therapy, Cervical Spondylosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shady Abdelsattar RefaatUniversity, hospital or other
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study will be conducted to investigate the effect of cupping therapy on the nitric oxide level in patients with cervical spondylosis
Detailed description
Cupping therapy is one of the oldest alternative medical procedures, along with acupuncture, with more than 3500 years of history to treat pain and various disorders. Cupping induces various biological responses that could be evoked by suction of the skin, About 5 to 10 minutes of cupping causes extravascular blood within the subcutaneous tissue and creates bruise-like marks. Therefore, cupping induces mild damage to a painful part of the body and accelerates healing by evoking the natural healing process. While this hypothesis is acceptable for some people, it might not be enough to change the minds of skeptics since cupping itself has no curative effects. Suppose the healing process after cupping can be accelerated by merging cupping with scientifically proven techniques. In that case, this new form of therapy might help to persuade skeptics of the efficacy of cupping. Integrative medicine, including acupuncture, dry needling, and cupping, is being used increasingly in the United States. evidence regarding their efficacy in the management of musculoskeletal conditions is heterogeneous and subject to several limitations. despite these limitations, acupuncture consistently is more effective than no treatment and is relatively safe. for chronic back pain, it is recommended as a first-line noninvasive therapy. for neck pain, acupuncture provides benefits when it is combined with other treatments. dry needling is similar to acupuncture and frequently is regarded as a form of acupuncture. sixty patients with cervical spondylosis will receive cupping therapy for three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cupping therapy
| Arm | Type | Receives |
|---|---|---|
| cupping therapy | Experimental | Other: cupping therapypatients with cervical spondylosis will receive cupping therapy one time per month for three months |
Who may qualify
- Ages
- 24 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with (cervical spondylosis) from both sexes.
- Age range (24-60) in chronic stages.
- BMI from20-25 kg/m2.
Key exclusion criteria (5 listed)
- Renal and hepatic patients.
- Anemia, hepatic disease, and dermatological diseases.
- Morbid obese patients if their BMI exceeds the 25 kg/m2 will be also excluded.
- the patients are taking any medications known to affect the pain level
- The patients have a systemic illness, dermatological problems, skin allergy, local ischemic problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cupping therapyAll the patients will be asked to be in a sitting position with both feet flat on the floor the cupping group will receive the cupping bloodletting at three acupuncture points (SI15, GB21, LI15) the medium size glass with a diameter of 4cm and a volume of 260ml. Each wet cupping treatment procedure will last about 20 min and will be conducted in five steps. 1. -Primary sucking 2. -Scarification 3- Bloodletting 4-Removal 5 -Dressing | Other | cupping therapy |
Primary outcome
the nitric oxide level
Time frame: up to three months
Spectrophotometer device will be used to measure the level of nitric oxide
2 secondary outcomes
cervical range of motion
Time frame: up to three months
pain intensity
Time frame: up to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cupping therapy in people with Cervical Spondylosis, run by Shady Abdelsattar Refaat.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
the nitric oxide level (time frame: up to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2024.