Prediction of Recovery in Patients With Neck Pain

NCT04924764 | Unknown

• 1 other identifier: REC/0876 Seerat Rashid
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Chronic Neck Pain; Cervical Radiculopathy

Keywords

Prediction Model; neck pain; recovery; chronic; sub acute

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to 2 months

Secondary Outcomes (1)

• Pain Anxiety symptom scale

  Up to 2 months

Study Arms (2)

Follow-up on daily basis

ACTIVE COMPARATOR

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

Other: Conventional physical therapy.

Follow-up on alternate days

ACTIVE COMPARATOR

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

Other: Conventional physical therapy.

Interventions

Conventional physical therapy. OTHER

Conventionally used intervention for subacute and chronic neck pain.

Follow-up on alternate days; Follow-up on daily basis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subacute and chronic neck pain.
• Patients with neck pain with a score of 4-10 on the numeric pain rating scale.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Helping Hand Institute of Rehabilitation Sciences

Mansehra, KPK, 21300, Pakistan

RECRUITING

Related Publications (2)

• 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.

  PMID: 21240529 BACKGROUND

• 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.

  PMID: 30327908 BACKGROUND

MeSH Terms

Conditions

Neck Pain; Radiculopathy; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Imran Amjad, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 14, 2021
• Study Start: June 15, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)