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Active, not recruitingNCT06457529Updated Jun 13, 2024

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

An interventional study of conventional treatment with Prolotherapy and Dry Needling and conventional treatment in Cervical Radiculopathy, sponsored by Superior University. Active, not recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by Superior University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Oct 2023, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Cervical Radiculopathy

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03

In context

Radiculopathy

488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 376 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

Superior University is the lead sponsor of 242 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    conventional treatment with Prolotherapy

    Diagnostic Test: conventional treatment with Prolotherapy

  • Other
    Dry Needling and conventional treatment

    Other: Dry Needling and conventional treatment

Interventions

  • Diagnostic testconventional 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.

  • OtherDry 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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 Months

  2. 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

    Time frame: 12 months

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Study locations

1 site
  • Iqbal Mahmooda Hospital, Iffat Anwar Medical Complex and Life line Hospital
    Lahore, Punjab, Pakistan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06457529
Lead sponsor
Superior University
Responsible party
Muhammad Naveed Babur (Principal Investigator, Superior University) — Principal investigator
First posted
Jun 13, 2024
Start date
Oct 1, 2023
Primary completion
May 1, 2024
Completion
Sep 30, 2024 (estimated)
Last update
Jun 13, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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