NCT05007119

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
Last Updated

August 16, 2021

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

August 11, 2021

Last Update Submit

August 11, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale for Pain

    8 weeks

  • Health Related Quality of life

    8 weeks

Study Arms (2)

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

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

Procedure: Mckenzie Extension ProtocolProcedure: Cupping

Interventions

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

Control GroupExperimental Group
CuppingPROCEDURE

Cupping with blood letting

Experimental Group

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female population of age between 30 to 50 years.
  • Female patients with diagnosed low back pain.

You may not qualify if:

  • Female population with cardiological, neurological, circulatory and orthopedic problems opens wounds or bone fractures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 46000, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Cupping Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 16, 2021

Study Start

July 10, 2020

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

August 16, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations