Prediction of Recovery in Patients With Neck Pain
Primary Purpose
Neck Pain, Chronic Neck Pain, Cervical Radiculopathy
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional physical therapy.
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Prediction Model, neck pain, recovery, chronic, sub acute
Eligibility Criteria
Inclusion Criteria:
- Subacute and chronic neck pain.
- Patients with neck pain with a score of 4-10 on the numeric pain rating scale.
Exclusion Criteria:
- 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
Sites / Locations
- Helping Hand Institute of Rehabilitation SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Follow-up on daily basis
Follow-up on alternate days
Arm Description
Patient receiving treatments on daily basis (5 days a week)
Patients receiving treatment on alternate days (3 days a week)
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04924764
First Posted
May 19, 2021
Last Updated
February 4, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04924764
Brief Title
Prediction of Recovery in Patients With Neck Pain
Official Title
Prediction of Recovery in Patients With Neck Pain: Prospective Longitudinal Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Chronic Neck Pain, Cervical Radiculopathy
Keywords
Prediction Model, neck pain, recovery, chronic, sub acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Follow-up on daily basis
Arm Type
Active Comparator
Arm Description
Patient receiving treatments on daily basis (5 days a week)
Arm Title
Follow-up on alternate days
Arm Type
Active Comparator
Arm Description
Patients receiving treatment on alternate days (3 days a week)
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy.
Intervention Description
Conventionally used intervention for subacute and chronic neck pain.
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
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.
Time Frame
Up to 2 months
Title
Neck disability index
Description
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.
Time Frame
Up to 2 months
Title
Range of Motion
Description
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.
Time Frame
Up to 2 months
Title
Manual muscle testing for strength of cervical muscle
Description
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.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Pain Anxiety symptom scale
Description
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.
Time Frame
Up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subacute and chronic neck pain.
Patients with neck pain with a score of 4-10 on the numeric pain rating scale.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helping Hand Institute of Rehabilitation Sciences
City
Mansehra
State/Province
KPK
ZIP/Postal Code
21300
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keramat Ullah
Phone
0997440424
Email
karamatjee@yahoo.com
First Name & Middle Initial & Last Name & Degree
Seerat Rashid
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21240529
Citation
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.
Results Reference
background
PubMed Identifier
30327908
Citation
Sleijser-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.
Results Reference
background
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Prediction of Recovery in Patients With Neck Pain
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