Cervical RadiculopathyNCT06457529
The Effect of Dry Needling and Prolotherapy on Pain, Function, and Quality of Life in Patients With Cervical Radiculopathy.
A study testing conventional treatment with Prolotherapy and Dry Needling and conventional treatment in people with Cervical Radiculopathy, run by Superior University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- conventional treatment with Prolotherapy and Dry Needling and conventional treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 30 Sep 2024
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Iqbal Mahmooda Hospital, Iffat Anwar Medical Complex and Life line Hospital
Lahore, Punjab Province
About this study
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.
- Conditions
- Cervical Radiculopathy
- Being tested
- conventional treatment with Prolotherapy, Dry Needling and conventional treatment
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional treatment with ProlotherapyDiagnostic test
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.
Dry Needling and conventional treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment with Prolotherapy | Experimental | Not described Receives: Diagnostic Test: conventional treatment with Prolotherapy |
| Dry Needling and conventional treatment | Other | Not described Receives: Other: Dry Needling and conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457529
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/721
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dry Needling and Prolotherapy on Pain, Function, and Quality of Life in Patients With Cervical Radiculopathy.
- ClinicalTrials.gov ID
- NCT06457529
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/721
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 13 Jun 2024 (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.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional treatment with Prolotherapy | Experimental | Diagnostic Test: conventional treatment with Prolotherapy |
| Dry Needling and conventional treatment | Other | Other: Dry Needling and conventional treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| conventional treatment with ProlotherapyGroup 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. | Diagnostic test | conventional treatment with Prolotherapy |
| Dry Needling and conventional treatmentGroup 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 | Other | Dry Needling and conventional treatment |
Primary outcome
Neck Disability Index
Time frame: 12 Months
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
WHO Quality of Life
Time frame: 12 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Cervical Radiculopathy
Recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
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 conventional treatment with Prolotherapy and Dry Needling and conventional treatment in people with Cervical Radiculopathy, run by Superior University 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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?
Results are not available in the source record.
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?
Neck Disability Index (time frame: 12 Months). 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 13 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.