Neck PainNCT04924764
Prediction of Recovery in Patients With Neck Pain
A study testing Conventional physical therapy. in people with Neck Pain and Chronic Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
This prognostic prediction model will be a reference for the health care professionals in clinical decision making and subsequent outcomes in dealing with patients having sub-acute and chronic neck pain, as well as, it will be a guide regarding therapeutic management and patients' education. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain, Chronic Neck Pain, Cervical Radiculopathy
- What is being tested?
- Conventional physical therapy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2021to 30 Apr 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subacute and chronic neck pain.
- Patients with neck pain with a score of 4-10 on the numeric pain rating scale.
Who cannot join
- Acute neck pain.
- Neck pain due to fracture, tumour, infection or metabolic bone disease.
- History of cervical spine injury or surgery.
- Patients presented with disc herniation.
- Cervical instability
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Helping Hand Institute of Rehabilitation Sciences
Mansehra, KPK, 21300
Keramat Ullah, 0997440424, karamatjee@yahoo.com
Seerat Rashid
About this study
Official title: Prediction of Recovery in Patients With Neck Pain: Prospective Longitudinal Study
This prognostic prediction model will be a reference for the health care professionals in clinical decision making and subsequent outcomes in dealing with patients having sub-acute and chronic neck pain, as well as, it will be a guide regarding therapeutic management and patients' education. Although various studies have evaluated the prognostic factors for individual neck pain conditions or treatment, to author Knowledge, no such prognostic model is available yet that predict the recovery in patients of sub-acute and chronic neck pain when managed conservatively. Therefore, this study is aimed to create a prediction model suggesting the recovery time for neck pain.
Read the detailed description
Neck pain is a highly prevalent condition that leads to considerable pain, disability, and economic cost. It not only constitutes a major personal burden but also affects families, the health system and the economic structure of countries. Neck pain is described as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage" in the neck region, which starts at the superior nuchal line and continues down to the level of the scapular spine. Acute, sub-acute and chronic neck pain is defined as neck pain with full-time sick-listing for 0 - 21 days (3 weeks), 22 - 84 days (4-12 weeks) and more than 12 weeks, respectively. A number of studies have explored prognostic factors for neck pain. Most frequently reported prognostic factors are age, gender, pain severity, a history of neck pain, concomitant low back pain, duration of pain, occupation, previous trauma, and degenerative changes on X-ray. Physiotherapy interventions for chronic neck pain showing the strongest support for an effect on pain are strength and endurance training. Two of the most widely used treatment strategies for the management of neck pain is exercise therapy (ET) and manual therapy (MT). ET is defined as a regimen or plan of physical activities designed and prescribed for any therapeutic goals, which includes strength exercises, stabilization exercises and endurance exercises. MT may is defined as "the use of hands to apply a force with therapeutic intent. various studies have evaluated the prognostic factors for individual neck pain conditions or treatment. but the author Knowledge, no such prognostic model is available yet that predict the recovery in patients of sub-acute and chronic neck pain when managed conservatively.
- Conditions
- Neck Pain, Chronic Neck Pain, Cervical Radiculopathy
- Being tested
- Conventional physical therapy.
- Keywords
- Prediction Model, neck pain, recovery, chronic, sub acute
- Medical subject headings
- Neck Pain, Radiculopathy, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapy.Other
Conventionally used intervention for subacute and chronic neck pain.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up on daily basis | Active comparator | Patient receiving treatments on daily basis (5 days a week) Receives: Other: Conventional physical therapy. |
| Follow-up on alternate days | Active comparator | Patients receiving treatment on alternate days (3 days a week) Receives: Other: Conventional physical therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
The Numeric pain rating scale (NPRS) is a self-reported, or clinician-administered, measurement tool consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form. The patient is asked to rate his/her pain intensity and a particular time frame or descriptor is established (e.g. within the last 24 h, today, worst pain, average pain, or least pain). The NPRS scores are high on ease of administration and simplicity for scoring. The last reading will be taken when the NPRS score will be less than 3.
Measured: Up to 2 months
Neck disability index
The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain-related disability. The NDI is the most widely used, translated and oldest questionnaire for neck pain. Questions include activities of daily living, such as personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration and headache. Each question is measured on a scale from 0 (no disability) to 5, and an overall score out of 100 is calculated by adding each item score together and multiplying it by two. A higher NDI score means the greater a patient's perceived disability due to neck pain. The "minimally clinically important change" by patients has been found to be 5 or 10%. The last reading will be taken when the NPRS score will be less than 3.
Measured: Up to 2 months
Range of Motion
Goniometric measurements are used by physical therapists to quantify baseline limitations of motion, decide on appropriate therapeutic interventions, and document the effectiveness of these interventions. Goniometry can be considered a fundamental part of the "basic science" of physical therapy. To most physical therapists, however, the universal goniometer (i.e. full-circle manual goniometer) remains the most versatile and widely used instrument in clinical practice. The last reading will be taken when the NPRS score will be less than 3.
Measured: Up to 2 months
Manual muscle testing for strength of cervical muscle
Medical Research Council Manual Muscle Testing scale is the most commonly accepted method of evaluating muscle strength. This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly; 0 means no muscle activation, 1 means trace muscle activation, such as a twitch, without achieving full Range of Motion (ROM), 2 means muscle activation with gravity eliminated, achieving full ROM, 3 means muscle activation against gravity, full ROM, 4 means muscle activation against some resistance, full ROM, 5 means muscle activation against examiner's full resistance, full ROM. The last reading will be taken when the NPRS score will be less than 3.
Measured: Up to 2 months
Secondary outcomes (1)
Pain Anxiety symptom scale
The Pain Anxiety symptom scale -20 (PASS-20) was constructed by extracting 20 items from its 40-item parent measure Pain Anxiety symptom scale (PASS) (18). The PASS-20 is a 20-item self-report instrument, measuring 4 factorially distinct components of pain-related anxiety. The cognitive subscale assesses cognitive anxiety symptoms, such as racing thoughts and impaired concentration due to pain. The fear subscale assesses fearful thoughts and anticipated negative consequences of pain. The escape/avoidance subscale assesses behavioural responses that reduce or terminate pain. The physiological anxiety subscale assesses physiological arousal in response to pain. Each item is rated on a 6-point Likert scale ranging from 0 (never) to 5 (always). Summing each subscale provides a score that can be considered a general measure of pain-related anxiety. The last reading will be taken when the NPRS score will be less than 3.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start15 Jun 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924764
- Sponsor's protocol ID
- REC/0876 Seerat Rashid
- Status last verified
- Feb 2022
- First submitted
- 19 May 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cai C, Ming G, Ng LY. Development of a clinical prediction rule to identify patients with neck pain who are likely to benefit from home-based mechanical cervical traction. Eur Spine J. 2011 Jun;20(6):912-22. doi: 10.1007/s00586-010-1673-6. Epub 2011 Jan 15.
PubMed 21240529Sleijser-Koehorst MLS, Coppieters MW, Heymans MW, Rooker S, Verhagen AP, Scholten-Peeters GGM. Clinical course and prognostic models for the conservative management of cervical radiculopathy: a prospective cohort study. Eur Spine J. 2018 Nov;27(11):2710-2719. doi: 10.1007/s00586-018-5777-8. Epub 2018 Oct 16.
PubMed 30327908
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Recovery in Patients With Neck Pain: Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT04924764
- Acronym / sponsor ID
- REC/0876 Seerat Rashid
- Conditions
- Neck Pain, Chronic Neck Pain, Cervical Radiculopathy
- Keywords
- Prediction Model, neck pain, recovery, chronic, sub acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 14 Jun 2021 (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.
This prognostic prediction model will be a reference for the health care professionals in clinical decision making and subsequent outcomes in dealing with patients having sub-acute and chronic neck pain, as well as, it will be a guide regarding therapeutic management and patients' education. Although various studies have evaluated the prognostic factors for individual neck pain conditions or treatment, to author Knowledge, no such prognostic model is available yet that predict the recovery in patients of sub-acute and chronic neck pain when managed conservatively. Therefore, this study is aimed to create a prediction model suggesting the recovery time for neck pain.
Detailed description
Neck pain is a highly prevalent condition that leads to considerable pain, disability, and economic cost. It not only constitutes a major personal burden but also affects families, the health system and the economic structure of countries. Neck pain is described as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage" in the neck region, which starts at the superior nuchal line and continues down to the level of the scapular spine. Acute, sub-acute and chronic neck pain is defined as neck pain with full-time sick-listing for 0 - 21 days (3 weeks), 22 - 84 days (4-12 weeks) and more than 12 weeks, respectively. A number of studies have explored prognostic factors for neck pain. Most frequently reported prognostic factors are age, gender, pain severity, a history of neck pain, concomitant low back pain, duration of pain, occupation, previous trauma, and degenerative changes on X-ray. Physiotherapy interventions for chronic neck pain showing the strongest support for an effect on pain are strength and endurance training. Two of the most widely used treatment strategies for the management of neck pain is exercise therapy (ET) and manual therapy (MT). ET is defined as a regimen or plan of physical activities designed and prescribed for any therapeutic goals, which includes strength exercises, stabilization exercises and endurance exercises. MT may is defined as "the use of hands to apply a force with therapeutic intent. various studies have evaluated the prognostic factors for individual neck pain conditions or treatment. but the author Knowledge, no such prognostic model is available yet that predict the recovery in patients of sub-acute and chronic neck pain when managed conservatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up on daily basis | Active comparator | Other: Conventional physical therapy.Patient receiving treatments on daily basis (5 days a week) |
| Follow-up on alternate days | Active comparator | Other: Conventional physical therapy.Patients receiving treatment on alternate days (3 days a week) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subacute and chronic neck pain.
- Patients with neck pain with a score of 4-10 on the numeric pain rating scale.
Key exclusion criteria (5 listed)
- Acute neck pain.
- Neck pain due to fracture, tumour, infection or metabolic bone disease.
- History of cervical spine injury or surgery.
- Patients presented with disc herniation.
- Cervical instability
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 physical therapy.Conventionally used intervention for subacute and chronic neck pain. | Other | Follow-up on alternate days, Follow-up on daily basis |
Primary outcome
Numeric pain rating scale
Time frame: Up to 2 months
The Numeric pain rating scale (NPRS) is a self-reported, or clinician-administered, measurement tool consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form. The patient is asked to rate his/her pain intensity and a particular time frame or descriptor is established (e.g. within the last 24 h, today, worst pain, average pain, or least pain). The NPRS scores are high on ease of administration and simplicity for scoring. The last reading will be taken when the NPRS score will be less than 3.
Neck disability index
Time frame: Up to 2 months
The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain-related disability. The NDI is the most widely used, translated and oldest questionnaire for neck pain. Questions include activities of daily living, such as personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration and headache. Each question is measured on a scale from 0 (no disability) to 5, and an overall score out of 100 is calculated by adding each item score together and multiplying it by two. A higher NDI score means the greater a patient's perceived disability due to neck pain. The "minimally clinically important change" by patients has been found to be 5 or 10%. The last reading will be taken when the NPRS score will be less than 3.
Range of Motion
Time frame: Up to 2 months
Goniometric measurements are used by physical therapists to quantify baseline limitations of motion, decide on appropriate therapeutic interventions, and document the effectiveness of these interventions. Goniometry can be considered a fundamental part of the "basic science" of physical therapy. To most physical therapists, however, the universal goniometer (i.e. full-circle manual goniometer) remains the most versatile and widely used instrument in clinical practice. The last reading will be taken when the NPRS score will be less than 3.
Manual muscle testing for strength of cervical muscle
Time frame: Up to 2 months
Medical Research Council Manual Muscle Testing scale is the most commonly accepted method of evaluating muscle strength. This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly; 0 means no muscle activation, 1 means trace muscle activation, such as a twitch, without achieving full Range of Motion (ROM), 2 means muscle activation with gravity eliminated, achieving full ROM, 3 means muscle activation against gravity, full ROM, 4 means muscle activation against some resistance, full ROM, 5 means muscle activation against examiner's full resistance, full ROM. The last reading will be taken when the NPRS score will be less than 3.
1 secondary outcome
Pain Anxiety symptom scale
Time frame: Up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Background: PubMed 21240529Cai C, Ming G, Ng LY. Development of a clinical prediction rule to identify patients with neck pain who are likely to benefit from home-based mechanical cervical traction. Eur Spine J. 2011 Jun;20(6):912-22. doi: 10.1007/s00586-010-1673-6. Epub 2011 Jan 15.
- Background: PubMed 30327908Sleijser-Koehorst MLS, Coppieters MW, Heymans MW, Rooker S, Verhagen AP, Scholten-Peeters GGM. Clinical course and prognostic models for the conservative management of cervical radiculopathy: a prospective cohort study. Eur Spine J. 2018 Nov;27(11):2710-2719. doi: 10.1007/s00586-018-5777-8. Epub 2018 Oct 16.
- Individual participant dataSharing planned: No
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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.
Imran Amjad, PhD 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 Conventional physical therapy. in people with Neck Pain and Chronic Neck Pain, 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 2 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 7 Feb 2022. 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?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: Up to 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04924764, which also lists 2 linked publications.
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 7 Feb 2022.