The Effect of Dry Needling and Prolotherapy on Pain, Function, and Quality of Life in Patients With Cervical Radiculopathy.

Cervical Radiculopathy Clinical Trial

Official title:

The Effect of Dry Needling and Prolotherapy on Pain, Function, and Quality of Life in Patients With Cervical Radiculopathy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06457529
• Other study ID #: MSRSW/Batch-Fall22/721
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Superior University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hyperosmolar dextrose is the most common agent. Administering proliferant substances can accelerate the tissue healing process by inducing cellular rupture and inflammatory response, leading to collagen deposition, cellular growth factor production, and regeneration. Dry needling used to relieve trigger point release in deep and superficial muscles. Both treatment interventions will apply to cervical radiculopathy patients to measure the effectiveness of treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Diagnostic Test:
• conventional treatment with Prolotherapy
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.

Other:
• Dry Needling and conventional treatment
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

Locations

Country	Name	City	State
Pakistan	Iqbal Mahmooda Hospital, Iffat Anwar Medical Complex and Life line Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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