CClinicalTrials.gg
Status unknownNCT04924764Updated Feb 7, 2022

Prediction of Recovery in Patients With Neck Pain

An interventional study of Conventional physical therapy. in Neck Pain, Chronic Neck Pain and Cervical Radiculopathy, sponsored by Riphah International University. Status unknown at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-02-07.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Neck Pain
  • Chronic Neck Pain
  • Cervical Radiculopathy

Keywords

  • Prediction Model
  • neck pain
  • recovery
  • chronic
  • sub acute
03

In context

Radiculopathy

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

This study's planned enrollment of 84 is above the median of 60 across 376 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Active comparator
    Follow-up on daily basis

    Patient receiving treatments on daily basis (5 days a week)

    Other: Conventional physical therapy.

  • Active comparator
    Follow-up on alternate days

    Patients receiving treatment on alternate days (3 days a week)

    Other: Conventional physical therapy.

Interventions

  • OtherConventional physical therapy.

    Conventionally used intervention for subacute and chronic neck pain.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 2 months

  2. 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.

    Time frame: Up to 2 months

  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.

    Time frame: Up to 2 months

  4. 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.

    Time frame: 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.

    Time frame: Up to 2 months

07

Study locations

1 of 1 sites recruiting
  • Helping Hand Institute of Rehabilitation Sciences
    Mansehra, KPK 21300, Pakistan
    • Keramat Ullah · Contact · karamatjee@yahoo.com · 0997440424
    • Seerat Rashid · Principal investigator
    Recruiting
08

References and documents

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 21240529 ↗
  • 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. PubMed 30327908 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04924764
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jun 14, 2021
Start date
Jun 15, 2021
Primary completion
Apr 30, 2022 (estimated)
Completion
Apr 30, 2022 (estimated)
Last update
Feb 7, 2022

Study contacts

Imran Amjad, PhD
Contact
imran.amjad@riphah.edu.pk
03324390125
Imran Amjad, PhD
principal investigator · Riphah International University

Oversight

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

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