Low Back PainNCT05007119
"Cupping Therapy Combined With Conventional Physical Therapy Improves Pain and Health Related Quality of Life Among Female Patients of Low Back Pain''
A study testing Mckenzie Extension Protocol and Cupping in people with Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
A randomized control trial will be done on diagnosed Low Back Pain patients in Fauji Foundation Hospital Rawalpindi. There is a growing interest and demand in the field of Complementary And Alternative Medicine(CAM), nowadays .The purpose of the study is to determine the effects of cupping therapy combined with… Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Mckenzie Extension Protocol and Cupping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jul 2020to 1 Dec 2020
- 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female population of age between 30 to 50 years.
- Female patients with diagnosed low back pain.
Who cannot join
- Female population with cardiological, neurological, circulatory and orthopedic problems opens wounds or bone fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Cupping Therapy Combined With Conventional PT Improves Pain and Health Related Quality of Life Among Female Patients of Low Back Pain''
A randomized control trial will be done on diagnosed Low Back Pain patients in Fauji Foundation Hospital Rawalpindi. There is a growing interest and demand in the field of Complementary And Alternative Medicine(CAM), nowadays .The purpose of the study is to determine the effects of cupping therapy combined with conventional physical therapy to exercise to lower the pain and improve the health related quality of life of the patient using the modified SF - 36 scale. The conventional physical therapy includes hot pack placed on the low back region for ten minutes, interferential current therapy was used which has four round electrodes measuring 2.75 inches placed on the desired area(low back) waveform used was IFC- 4p , having a carrier frequency of 4000 Hz and a frequency of 80/150 Hz, vector scan was off , the intensity was increased manually according to the capacity of the patient and the treatment time was 15 minutes, strenghtening exercises such as william flexion were done once in the rehabilition center and patient was given a home plan to follow twice daily with 15 repitions each.
Read the detailed description
Experimental Group (A) = This group will receive cupping therapy every month combined with conventional physical therapy whhich includes hot pack , interferential therapy and streghtening exercises for back and their outcomes wi;; be measured at baseline and at the end of 6th month treatment..
Control group (B) =this group will not receive cuppping therapy , only conventional Physical therapy will be given and their outcomes will be observed at the baseline and then after treatment of 06 months.
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study within the community using the VAS scale.
A printed questionnaire will be provided to the parents after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
This study will make people become aware of their current physical fitness level, so the lifestyle behaviors can be modified if needed, in order to improve their quality of life This study will help create awareness among the people, it is not only economically accessible but also have very little chances of side effects This study will open new doors for researchers to do long term studies on different types of pain with different exercise types.
- Conditions
- Low Back Pain
- Being tested
- Mckenzie Extension Protocol, Cupping
- 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.
Mckenzie Extension ProtocolProcedure or surgery
Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence
Static:
- Lying Prone
- Lying prone in extension
- Sustained extension
- Posture correction Dynamic:
- Extension in lying
- Extension in lying with clinician overpressure
- Extension mobilization
- Extension in standing
CuppingProcedure or surgery
Cupping with blood letting
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | It includes participants receiving conventional physical therapy for low back pain female patients for a period of 6 months.
McKenzie extension exercise Protocol Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence
Static:
1. Lying Prone
2. Lying prone in extension
3. Sustained extension
4. Posture correction
Dynamic:
5. Extension in lying
6. Extension in lying with clinician overpressure
7. Extension mobilization
8. Extension in standing Receives: Procedure: Mckenzie Extension Protocol |
| Experimental Group | Experimental | Group (A) Involves participants receiving cupping therapy along with conventional physicla therapy for a period of 6 months .
Moist Heat Pack for 10 mins McKenzie Extension Exercise Protocol Receives: Procedure: Mckenzie Extension Protocol; Procedure: Cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for Pain
Measured: 8 weeks
Health Related Quality of life
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start10 Jul 2020
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007119
- Sponsor's protocol ID
- FUI/CTR/2020/9
- Status last verified
- Jul 2020
- First submitted
- 11 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Cupping Therapy Combined With Conventional PT Improves Pain and Health Related Quality of Life Among Female Patients of Low Back Pain''
- ClinicalTrials.gov ID
- NCT05007119
- Acronym / sponsor ID
- FUI/CTR/2020/9
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 16 Aug 2021 (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.
A randomized control trial will be done on diagnosed Low Back Pain patients in Fauji Foundation Hospital Rawalpindi. There is a growing interest and demand in the field of Complementary And Alternative Medicine(CAM), nowadays .The purpose of the study is to determine the effects of cupping therapy combined with conventional physical therapy to exercise to lower the pain and improve the health related quality of life of the patient using the modified SF - 36 scale. The conventional physical therapy includes hot pack placed on the low back region for ten minutes, interferential current therapy was used which has four round electrodes measuring 2.75 inches placed on the desired area(low back) waveform used was IFC- 4p , having a carrier frequency of 4000 Hz and a frequency of 80/150 Hz, vector scan was off , the intensity was increased manually according to the capacity of the patient and the treatment time was 15 minutes, strenghtening exercises such as william flexion were done once in the rehabilition center and patient was given a home plan to follow twice daily with 15 repitions each.
Detailed description
Experimental Group (A) = This group will receive cupping therapy every month combined with conventional physical therapy whhich includes hot pack , interferential therapy and streghtening exercises for back and their outcomes wi;; be measured at baseline and at the end of 6th month treatment..
Control group (B) =this group will not receive cuppping therapy , only conventional Physical therapy will be given and their outcomes will be observed at the baseline and then after treatment of 06 months.
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study within the community using the VAS scale.
A printed questionnaire will be provided to the parents after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
This study will make people become aware of their current physical fitness level, so the lifestyle behaviors can be modified if needed, in order to improve their quality of life This study will help create awareness among the people, it is not only economically accessible but also have very little chances of side effects This study will open new doors for researchers to do long term studies on different types of pain with different exercise types.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Mckenzie Extension ProtocolIt includes participants receiving conventional physical therapy for low back pain female patients for a period of 6 months. McKenzie extension exercise Protocol Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence Static: 1. Lying Prone 2. Lying prone in extension 3. Sustained extension 4. Posture correction Dynamic: 5. Extension in lying 6. Extension in lying with clinician overpressure 7. Extension mobilization 8. Extension in standing |
| Experimental Group | Experimental | Procedure: Mckenzie Extension Protocol, Procedure: CuppingGroup (A) Involves participants receiving cupping therapy along with conventional physicla therapy for a period of 6 months . Moist Heat Pack for 10 mins McKenzie Extension Exercise Protocol |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female population of age between 30 to 50 years.
- Female patients with diagnosed low back pain.
Key exclusion criteria (1 listed)
- Female population with cardiological, neurological, circulatory and orthopedic problems opens wounds or bone fractures.
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 |
|---|---|---|
| Mckenzie Extension ProtocolMoist Heat Pack for 10 mins McKenzie Extension Protocol Sequence Static: 1. Lying Prone 2. Lying prone in extension 3. Sustained extension 4. Posture correction Dynamic: 5. Extension in lying 6. Extension in lying with clinician overpressure 7. Extension mobilization 8. Extension in standing | Procedure or surgery | Control Group, Experimental Group |
| CuppingCupping with blood letting | Procedure or surgery | Experimental Group |
Primary outcome
Visual Analogue Scale for Pain
Time frame: 8 weeks
Health Related Quality of life
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mckenzie Extension Protocol and Cupping in people with Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
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 2 inclusion and 1 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 16 Aug 2021. 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 Pakistan. 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. 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?
Visual Analogue Scale for Pain (time frame: 8 weeks). 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?
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 16 Aug 2021.