| CTRI Number |
CTRI/2024/07/070033 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing efficacy of two cupping methods for nerve pain running from back down to the leg. |
|
Scientific Title of Study
|
Effectiveness of dry cupping therapy versus myofascial cupping therapy on sciatica. A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anmol Mall |
| Designation |
MPT orthopedics student |
| Affiliation |
Lovely professional university |
| Address |
Lovely professional university
Department of Physiotherapy
Jalandhar Delhi G.T.Road Phagwara Punjab.
Jalandhar
PUNJAB
144411
India |
| Phone |
7997181309 |
| Fax |
|
| Email |
anmolmall143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrReema Rasotra |
| Designation |
Assistant Professor |
| Affiliation |
Lovely professional university |
| Address |
Lovely professional university
Department of Physiotherapy
Jalandhar Delhi G.T.Road Phagwara Punjab.
Jalandhar
PUNJAB
144411
India |
| Phone |
9888706015 |
| Fax |
|
| Email |
rasotra1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrReema Rasotra |
| Designation |
Assistant Professor |
| Affiliation |
Lovely professional university |
| Address |
Lovely professional university
Department of Physiotherapy
Jalandhar Delhi G.T.Road Phagwara Punjab.
Jalandhar
PUNJAB
144411
India |
| Phone |
9888706015 |
| Fax |
|
| Email |
rasotra1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lovely professional university Department of Physiotherapy Jalandhar Delhi G.T.Road Phagwara Punjab.
Jalandhar
PUNJAB
144411
India |
|
|
Primary Sponsor
|
| Name |
Anmol Mall |
| Address |
Lovely professional university Department of Physiotherapy Jalandhar Delhi G.T.Road Phagwara Punjab.
Jalandhar
PUNJAB
144411
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrReema Rasotra |
Lovely professional university
Department of physiotherapy
Jalandhar Delhi G.T.Road Phagwara Punjab. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrReema Rasotra |
Lovely professional university |
LPU OPD 3-105
Department of Physiotherapy
Jalandhar
PUNJAB |
9888706015
rasotra1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry cupping therapy
Myofascial cupping therapy |
Dry cupping therapy Group
Position of the patient
Patient will be placed comfortably in a prone position prior to the session supported by the pillows.
Technique
The therapist will apply suitable-sized suction cups to particular acupoints or tender points along the sciatic nerve pathway that is affected taking into account the size of the affected area.
The time that the cups are left in place is predetermined and can vary from 5 to 15 minutes based on the patients tolerance and the therapists judgment.
Following the designated duration the cups will be taken out and to improve circulation and ease any lingering pain the treatment area might be stretched or given a light massage.
Myofascial Cupping Therapy Group
Position of the patient
Patient will be placed comfortably in a prone position prior to the session supported by the pillows.
Technique
To enable the cups to move smoothly the therapist will massage oil or lubricant into the treatment area.
The affected area will be covered with suction cups and the therapist will glide carefully or apply cupping strokes the entire length of the sciatic nerve pathway.
The therapist may modify the cupping strokes speed and intensity in response to participant feedback and treatment outcome.
The duration of myofascial cupping therapy lasts about five to fifteen minutes.
Cupping points for sciatica
For the right leg: The points are 1,55,11,12,26,51.
1- The shoulder, the seventh vertebra (bone of spine) of the neck
55- Almost 3cm under the shoulder
11- Lumbar vertebrae a prominent bone at the lower back of the vertebra column
12- On the sides of 11, slightly upward, 5cm away from the spine
26- Bilaterally at the sides of the iliac bone
51- The thigh bone (femur)
Additionally, a cup is also applied over the calf area.
For the left leg: The points are 1,55,11,13,27,52.
1- The shoulder, the seventh vertebra (bone of spine) of the neck
55- Almost 3cm under the shoulder
11- Lumbar vertebra a prominent bone at the lower back of the vertebra column
13- On the sides of 11, slightly upward, 5cm away from the spine
27- Bilaterally at the sides of the iliac bone
52- The thigh bone (femur)
Additionally, a cup is also applied over the calf area.
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Sciatica from last 6 months.
Patients having sciatica due to PIVD lumbar spondylolisthesis.
Sciatica due to lower limb musculature.
Complaining of radiating pain from back to anterior thigh muscles, posterior thigh muscles, buttocks and calf muscle, posterolateral or anterolateral ankle and toe.
|
|
| ExclusionCriteria |
| Details |
Patients with a recent history of trauma or surgery involving the lumbar or pelvic region within the past six months.
Patients with severe medical conditions such as uncontrolled hypertension, cardiovascular diseases, or neurological disorders.
Individuals with contraindications to cupping therapy, such as skin conditions, bleeding disorders, or allergies to cupping materials.
Patients with cognitive impairment or uncooperative patients.
Patients with impaired sensations
Patients with psychological disorders.
Pregnant women. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visual analog scale |
At baseline
After 2 weeks
End of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
range of motion
manual muscle testing |
baseline
after 2 weeks
end of 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TitleEffectiveness of dry cupping therapy versus myofascial cupping therapy on sciatica. A randomized clinical trial.Novelty of the study Alternative Method of Treatment
Cupping therapy can be an alternative treatment option for sciatica, as compared to standard medical interventions such as medication or surgery. Examining the efficacy of cupping therapy offers a novel approach to the treatment of sciatica, particularly for those who do not respond to conventional therapies.
Ancient Method in Modern time period
Although cupping treatment has been used for a very long time, the effectiveness of cupping therapy for sciatica in modern times is being studied in this study.
Although cupping treatment is ancient, its precise mechanism of action in treating sciatica is unclear. The goal of this study is to better understand its mechanism of action in sciatica. Significance of the study Clinical Implications
Sciatica pain can be relieved by cupping treatment. If successful, it may provide patients who don’t react well to conventional therapies with an extra choice for care. If cupping therapy proves to be effective, it may provide sciatica sufferers a secure, non-invasive means of enhancing their quality of life and reducing pain.
Theoretical Understanding
We will better understand cupping therapy’s impact on the body by researching how it affects sciatica. More information regarding the benefits of cupping therapy for sciatica can help direct the creation of more specialized and successful therapies for this and related conditions. Cost-effectiveness
Cupping treatment has the possibility of helping save a lot of money for individuals as well as healthcare systems if it turns out to be a cost-effective alternative to more expensive therapies like surgery. Patients may save money using cupping therapy if it is demonstrated to be cost-effective and helpful in avoiding costly procedures. Aim of the study To evaluate and compare the therapeutic efficacy of dry cupping therapy and myofascial cupping therapy on sciatica.Objectives of the study Effectiveness of dry cupping therapy on pain reduction, range of motion and muscle strength among patients with sciatica.Effectiveness of myofascial cupping therapy on pain reduction, range of motion and muscle strength among patients with sciatica. Comparative effectiveness of dry cupping
therapy and myofascial cupping therapy on pain reduction,
range of motion and muscle strength among patients with sciatica. Hypothesis Null hypothesis There is no significant improvement on pain reduction, range of motion and muscle strength with dry cupping therapy on sciatica. There is no significant improvement on pain reduction, range of motion and muscle strength with myofascial cupping therapy on sciatica. Alternate hypothesis There is significant improvement on pain reduction, range of motion and muscle strength with dry cupping therapy on sciatica. There is significant improvement on pain reduction, range of motion and muscle strength with myofascial cupping therapy on sciatica.
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