Clinical trial NCT04924764: Prediction of Recovery in Patients With Neck Pain
Official title: Prediction of Recovery in Patients With Neck Pain: Prospective Longitudinal Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Chronic Neck Pain
Cervical Radiculopathy
Keywords: Prediction Model
neck pain
recovery
chronic
sub acute
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numeric pain rating scale
timeFrame: Up to 2 months
measure: Neck disability index
timeFrame: Up to 2 months
measure: Range of Motion
timeFrame: Up to 2 months
measure: Manual muscle testing for strength of cervical muscle
timeFrame: Up to 2 months
Secondary outcomes:
measure: Pain Anxiety symptom scale
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Mansehra
country: Pakistan
facility: Helping Hand Institute of Rehabilitation Sciences
state: KPK
Study officials:
affiliation: Riphah International University
name: Imran Amjad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.