The Effect of Dry Needling and Prolotherapy on Pain, Function, and Quality of Life in Patients With Cervical Radiculopathy.
1 other identifier
interventional
40
1 country
1
Brief Summary
Cervical radiculopathy is characterized by neurological dysfunction caused by compression and inflammation of the spinal nerves or nerve roots of the cervical spine. Rolotherapy is a regenerative therapeutic method that consists of injecting irritant solutions into the injured areas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedJune 13, 2024
June 1, 2024
7 months
June 10, 2024
June 10, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Neck Disability Index
The NDI has become a standard instrument for measuring self-rated disability due to neck pain and is used by both clinicians and researchers. Each of the 10 items scores from 0 to 5. The maximum score is 50. The obtained score can be multiplied by two to produce a percentage score
12 Months
WHO Quality of Life
The QOLS is a reliable and valid instrument for measuring quality of life from the perspective of the patient. It focuses on domains that come from the qualitative descriptions of a wide range of adults across gender, cultural and language groups.Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale (16, 17). The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep
12 months
Study Arms (2)
conventional treatment with Prolotherapy
EXPERIMENTALDry Needling and conventional treatment
OTHERInterventions
Group A got prolotherapy along with conven¬tional treatment, which includes ultrasonic therapy for 10 minutes. The intensity will be 3MHz at 1.0 watts/cm2. Prolotherapy is an injection treatment used to relieve pain. Your healthcare provider will inject a small amount of an irritant into your body. Dextrose (sugar) solution is the most commonly injected irritant. Proponents of prolotherapy claim it relieves pain by jumpstarting your body's natural healing abilities.
Group B Subjects in Group B will get Dry Needling along with conventional treatment, which includes ultrasonic therapy for 10 minutes. The intensity will be 3MHz at 1.0 watts/cm2. Trigger-point dry needling is an invasive procedure where a fine needle or acupuncture needle is inserted into the skin and muscle
Eligibility Criteria
You may qualify if:
- Age group between 20-50 years
- Both male and female
- Unilateral pain starting in the cervical spine and radiating to the upper limb.
- Pain aggravated by upper limb movement
- Restricted range of motion of arm
You may not qualify if:
- History of Spinal infection
- Spinal Cord Injury
- History of Vertebral tumor and factures
- History of cervical or intracranial surgery
- History of Radiating pain to bilateral upper limb.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Iqbal Mahmooda Hospital, Iffat Anwar Medical Complex and Life line Hospital
Lahore, Punjab Province, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 13, 2024
Study Start
October 1, 2023
Primary Completion
May 1, 2024
Study Completion
September 30, 2024
Last Updated
June 13, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share