Cervical RadiculopathyNCT05749835
Effects of Thoracic Screw Manipulation in Patients With Cervical Radiculopathy
A study testing Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy and Sustained Natural Apophyseal Glides and conventional therapy in people with Cervical Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cervical radiculopathy is a pain and/or sensorimotor deficit syndrome that is defined as being caused by compression of a cervical nerve root. The compression can occur as a result of disc herniation, Spondylosis, instability, trauma, or rarely, tumors. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy and Sustained Natural Apophyseal Glides and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 10 Jul 2023
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients complaint from pain in the cervical spine and pain or paresthesia traveling from the neck into a specific region of the arm, forearm or hand
- Cervical Lateral flexion and rotation <60 degree
- Positive scores on 3 of 4 clinical tests: Spurling's test, upper-limb neurodynamic test/median nerve bias, cervical distraction test, and cervical rotation toward the symptomatic side of less than 60°
- Hypomobility at T1- T5 thoracic vertebrae on springing test.
Who cannot join
- Participants with a history of vertebro-basilary artery insufficiency.
- Patient with history of cervical surgery or arthroplasty
- Patients with a positive history of trauma, fracture or surgery of the cervical
- spine
- Diagnosed cases of Torticollis, and scoliosis
- History of osteoporosis, Any heart disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The Physiotherapy clinic Saidpur Road
Rawalpindi, Punjab Province
About this study
Cervical radiculopathy is a pain and/or sensorimotor deficit syndrome that is defined as being caused by compression of a cervical nerve root. The compression can occur as a result of disc herniation, Spondylosis, instability, trauma, or rarely, tumors.
Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine
Read the detailed description
Patient presentations can range from complaints of pain, numbness, and/or tingling in the upper extremity to electrical type pains or even weakness. Disc herniation accounts for 20-25% of the cases of cervical radiculopathy. Most of the time cervical radiculopathy appears unilaterally; however it is possible for bilateral symptoms to be present if severe bony spurs are present at one level, impinging/irritating the nerve root on both sides. If peripheral radiation of pain, weakness, or pins and needle are present, the location of the pain will follow back to the concerned affected nerve root Manual techniques include positional release technique, muscle energy technique, myofascial release technique, Cyriax technique, Natural Apophyseal Glides and Sustained Natural Apophyseal Glides, manual pressure release, proprioceptive neuromuscular facilitation and ischemic compression.
Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine
- Conditions
- Cervical Radiculopathy
- Being tested
- Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy, Sustained Natural Apophyseal Glides and conventional therapy
- Keywords
- pain, thoracic manipulation, sustained natural epiphyseal glides, neck disability index
- Medical subject headings
- Radiculopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapyOther
After the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland.
Sustained Natural Apophyseal Glides and conventional therapyOther
Position of therapist: stands beside the patient, while his\her head is cradled between your body and your right forearm (when you stand at his\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7).
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy | Experimental | After the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland et al Receives: Other: Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy |
| Sustained Natural Apophyseal Glides and conventional therapy | Experimental | Position of therapist: stands beside the patient, while his\her head is cradled between your body and your right forearm (when you stand at his\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7). Receives: Other: Sustained Natural Apophyseal Glides and conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS (Numeric Pain Rating Scale).
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable.
Measured: four weeks
Inclinometer
Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry. Inclinometers are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87-0.95.
Measured: four weeks
(Neck Disability Index) Urdu
the neck disability index is a ten-item self-reported Questionnaire that assesses pain and associated disability, with a total max score of 50 points. An Urdu version of neck disability index will be used in this study. The total scores (ICC = 0.99) of the Neck Disability Index -Urdu.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Feb 2022
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
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 Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749835
- Sponsor's protocol ID
- HAMZA REC/Letter- 01392
- Status last verified
- Oct 2023
- First submitted
- 20 Feb 2023
- Last updated
- 12 Oct 2023
- 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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Screw Manipulation in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT05749835
- Acronym / sponsor ID
- HAMZA REC/Letter- 01392
- Conditions
- Cervical Radiculopathy
- Keywords
- pain, thoracic manipulation, sustained natural epiphyseal glides, neck disability index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 1 Mar 2023 (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 a pain and/or sensorimotor deficit syndrome that is defined as being caused by compression of a cervical nerve root. The compression can occur as a result of disc herniation, Spondylosis, instability, trauma, or rarely, tumors.
Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine
Detailed description
Patient presentations can range from complaints of pain, numbness, and/or tingling in the upper extremity to electrical type pains or even weakness. Disc herniation accounts for 20-25% of the cases of cervical radiculopathy. Most of the time cervical radiculopathy appears unilaterally; however it is possible for bilateral symptoms to be present if severe bony spurs are present at one level, impinging/irritating the nerve root on both sides. If peripheral radiation of pain, weakness, or pins and needle are present, the location of the pain will follow back to the concerned affected nerve root Manual techniques include positional release technique, muscle energy technique, myofascial release technique, Cyriax technique, Natural Apophyseal Glides and Sustained Natural Apophyseal Glides, manual pressure release, proprioceptive neuromuscular facilitation and ischemic compression.
Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy | Experimental | Other: Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapyAfter the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland et al |
| Sustained Natural Apophyseal Glides and conventional therapy | Experimental | Other: Sustained Natural Apophyseal Glides and conventional therapyPosition of therapist: stands beside the patient, while his\her head is cradled between your body and your right forearm (when you stand at his\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients complaint from pain in the cervical spine and pain or paresthesia traveling from the neck into a specific region of the arm, forearm or hand
- Cervical Lateral flexion and rotation <60 degree
- Positive scores on 3 of 4 clinical tests: Spurling's test, upper-limb neurodynamic test/median nerve bias, cervical distraction test, and cervical rotation toward the symptomatic side of less than 60°
- Hypomobility at T1- T5 thoracic vertebrae on springing test.
Key exclusion criteria (6 listed)
- Participants with a history of vertebro-basilary artery insufficiency.
- Patient with history of cervical surgery or arthroplasty
- Patients with a positive history of trauma, fracture or surgery of the cervical
- spine
- Diagnosed cases of Torticollis, and scoliosis
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 |
|---|---|---|
| Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapyAfter the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland. | Other | Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy |
| Sustained Natural Apophyseal Glides and conventional therapyPosition of therapist: stands beside the patient, while his\her head is cradled between your body and your right forearm (when you stand at his\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7). | Other | Sustained Natural Apophyseal Glides and conventional therapy |
Primary outcome
NPRS (Numeric Pain Rating Scale).
Time frame: four weeks
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable.
Inclinometer
Time frame: four weeks
Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry. Inclinometers are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87-0.95.
(Neck Disability Index) Urdu
Time frame: four weeks
the neck disability index is a ten-item self-reported Questionnaire that assesses pain and associated disability, with a total max score of 50 points. An Urdu version of neck disability index will be used in this study. The total scores (ICC = 0.99) of the Neck Disability Index -Urdu.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- 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.
maria Khalid, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy and Sustained Natural Apophyseal Glides and conventional therapy in people with Cervical Radiculopathy, run by Riphah International 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 12 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NPRS (Numeric Pain Rating Scale). (time frame: four weeks). The study lists 3 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 12 Oct 2023.