The Effectiveness of Patient-tailored Treatment in Patients With (Sub)Acute Neck Pain

NCT04182035 | Completed

• 1 other identifier: B670201941044
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to examine if a patient-tailored treatment program has a better effect on pain and disability than a non-patient tailored treatment or wait and see approach in patients with (sub)acute (recurrent) NSNP. A secondary goal is to evaluate the global perceived effect, treatment adherence, recurrence, work absenteeism and medication use. All interventional treatment arms will consist of a treatment part in a clinical practice setting, under supervision of a trained physiotherapist, and an educational intervention and will be compared to the control group.

Conditions

Neck Pain; Acute Pain; Rehabilitation; Physical Therapy Modalities

Keywords

stratified care; patient-tailored therapy; subacute

Outcome Measures

Primary Outcomes (2)

• Change in painscores in the neck region, overall pain score

  Numeric Rating Scale (score 0-10; 0=no pain; 10=worst pain)

  Baseline, every supervised treatment (Week 1-9),follow up 3 weeks,3,6,12 months post treatment

• Change in disability

  Neck Disability Index (score0-50; 0=no disability; 50=maximal disability)

  Baseline, every supervised treatment (9x), follow up 3 weeks,3,6,12 months post treatment

Secondary Outcomes (3)

• Change in Global Perceived Effect

  After 3,6 & 9 supervised treatments, follow up 3 weeks,follow up 3,6,12 months

• Change in medical costs

  At baseline, follow up 3 weeks,3,6,12 months post treatment

• Change in productivity costs

  At baseline, follow up 3 weeks,3,6,12 months post treatment

Study Arms (3)

Patient-tailored treatment group

EXPERIMENTAL

Objectives \& approach: The subjects in the PTT group will receive the individual tailored treatment program combining best evidence active and passive treatment strategies (manual therapy, individual exercises) in combination with education tailored to the individual situation of the patient and selected home exercises. 9 individual therapy sessions will be performed, in combination with 9 additional home exercise sessions.. NRS and NDI-scores will be monitored before every treatment. The therapist will register when the cut-off score of 30% NDI reduction is present in order to determine the evolution in pain/disability reduction. The importance of self-efficacy will be emphasized and tailored home-exercises will be monitored and adjusted every week.

Other: patient-tailored therapy; Other: Education

Non patient-tailored treatment group

ACTIVE COMPARATOR

Objectives \& approach: The NPTT will receive an individual (hands-off) treatment, which includes an active neck exercise program, non-tailored education and non-tailored home exercises, according to a previously published program with good results.53 The sessions will be performed once a week under supervision (9 therapy sessions, standard exercise program) and once a week by the patient at home (9 home exercise sessions, standard exercise program).

Other: Non-patient tailored therapy: generalized exercise program; Other: Education

Control group

NO INTERVENTION

The subjects randomized to the control group will not receive any intervention, if necessary medication use is permitted and will be monitored using the iMTAQ. Patients will be asked not to seek other treatment options (if possible). If this is not possible, patients will be considered lost to follow-up.

Interventions

patient-tailored therapy OTHER

The subjects in the PTT group will receive the individual tailored treatment program combining best evidence active and passive treatment strategies (manual therapy, individual exercises) in combination with education tailored to the individual situation of the patient and selected home exercises. 9 individual therapy sessions will be performed, in combination with 9 additional home exercise sessions.. NRS and NDI-scores will be monitored before every treatment. The therapist will register when the cut-off score of 30% NDI reduction is present in order to determine the evolution in pain/disability reduction. The importance of self-efficacy will be emphasized and tailored home-exercises will be monitored and adjusted every week.

Patient-tailored treatment group

Non-patient tailored therapy: generalized exercise program OTHER

The NPTT will receive an individual (hands-off) treatment, which includes an active neck exercise program, non-tailored education and non-tailored home exercises, according to a previously published program with good results.53 The sessions will be performed once a week under supervision (9 therapy sessions, standard exercise program) and once a week by the patient at home (9 home exercise sessions, standard exercise program).

Non patient-tailored treatment group

Education OTHER

Education considering neck pain information

Non patient-tailored treatment group; Patient-tailored treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-specific neck pain, pain located in the cervico-thoracic and posterior shoulder region; without dominant arm pain.
• NDI scores score ≥10 % (more than no disability) and ≤68 % (less than complete disability)
• (Sub)acute complaints: \<3 months
• Recurrent complaints but no neck pain episode the previous 3 months.
• Mean pain intensity scores: NRS \> 3/10

You may not qualify if:

• Structural pathology, confirmed by imaging (disk herniation, nerve root compression, radiculopathy, severe rheumatoid diseases, fractures, traumatic alterations…) Shoulder pathology, vestibular pathology.
• Risk stratification: Startback tool for neck pain: high risk group
• BMI \> 30 kg/m²
• Other cardiovascular/metabolic/systemic/ neurological diseases, fibromyalgia or chronic fatigue syndrome
• Psychiatric illnesses, history of depression, serious catastrophizing thoughts and/or low treatment expectations.\[52\]
• Chronic complaints (\>3 months) or traumatic onset of the complaints
• Probable or definite neuropathic pain (according to the classification of Finnerup et al.)
• History of surgery in the head/neck or shoulder region
• Hypermobile patients
• Pregnancy or given birth in the preceding year.
• History of recurrent/chronic low back pain
• Primary headache

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Marjolein Chys

Ichtegem, België, 8480, Belgium

Location

MeSH Terms

Conditions

Neck Pain; Acute Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Barbara Cagnie

  UGent

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: December 2, 2019
• Study Start: December 1, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)