Comparison Between Two Physical Therapy Treatments in Patients With Nonspecific Chronic Neck Pain

NCT04695730 | Completed

• 1 other identifier: 679/2020/Sper/AOUBo
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Non-specific chronic neck pain is a very prevalent condition in the population ranging from 45% to 54%. Several conservative treatments have been shown to be effective and are currently used in clinical practice. However, among the physical therapy ones, no study evaluated the effectiveness of Pompage techniques in addition to an active treatment. This protocol describes a controlled, randomized trial that aims to assess the effectiveness of two physical therapy treatments in patients with chronic non-specific neck pain. Methods: Seventy subjects with chronic nonspecific neck pain from 18 to 80 years will be recruited according to the inclusion criteria. Afterwards they will be randomized to one of the 2 groups: group 1 (G1) will undergo an active intervention and group 2 (G2) will receive the same active intervention plus manual technique. Active intervention, according to the current guidelines on non-specific neck pain, will be a treatment including both pain education and home exercises; manual technique will be the so-called "Pompage" technique. A booster session will be planned for both groups after 4 weeks from the beginning of the trial, to reinforce the patients adherence to the self-treatment. The patients will be evaluated before the treatments (baseline, T0), after 8 weeks from the beginning of the treatments (T1), and 6 months after the end of the treatments (T2). The primary outcome will be pain perception, which will be assessed using a Visual Analogue Scale (VAS). The secondary outcomes will be: kinesiophobia (measured with the Tampa Scale of Kinesiophobia - TSK), physical function (measured with the Neck Disability Index - NDI), active cervical range of motion - ROM (measured with the "CROM Deluxe" device), patient satisfaction for treatment (measured with the Physical Therapy Satisfaction Questionnaire - PTPSQI(15)), and subjective perception of improvement (measured with the Global Perceived Effect - GPE). Adverse effects will be registered. Discussion: Considering that there is no consensus on the use of Pompage techniques in addition to an active treatment in individuals with nonspecific chronic neck pain, our protocol will be the basis for the use of these techniques by health professionals and for new studies to be performed.

Conditions

Non-specific Chronic Neck Pain

Keywords

neck pain; chronic neck pain; musculoskeletal disorder

Outcome Measures

Primary Outcomes (1)

• Changes in neck pain

  Visual Analogue Scale (VAS). VAS is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]).

  At baseline, 8 weeks, and 6 months.

Secondary Outcomes (5)

• Changes in neck disability

  At baseline, 8 weeks, and 6 months.

• Changes in Kinesiophobia/Fear of movement

  At baseline, 8 weeks, and 6 months.

• Changes in Active Cervical Range of Motion

  At baseline, 8 weeks, and 6 months.

• Assessment of the satisfaction for physical therapy

  At 8 weeks and 6 months.

• Assessment of the global perception of improvement on a 7-points Likert Scale

  At 8 weeks and 6 months.

Study Arms (2)

Active physical therapy

ACTIVE COMPARATOR

Active intervention (including both pain education and home exercises). A 60-minutes education session will be provided, concerning pain mechanisms and management and a demonstration of the exercises to perform individually at home. Home exercises will be performed daily. To support patients during the treatment, a booklet will be created. One 30-minutes booster session will be planned after 4 weeks. Patients will follow this active intervention for 8 weeks.

Other: Active physical therapy (including both pain education and home exercises)

Active physical therapy plus manual therapy

EXPERIMENTAL

Participants in the Group 2 will receive active intervention plus 8 "Pompage" technique sessions (1 session/week). In these sessions (30 minutes each), "Pompage" technique will be performed by a physical therapist.

Other: Active physical therapy plus manual therapy

Interventions

Active physical therapy (including both pain education and home exercises) OTHER

One session (60 minutes). In this session, a physical therapist will explain and demonstrate the exercises to perform individually at home. Exercises will be performed daily. In addition, an education session will be provided, concerning pain mechanisms and management. To support patients during the treatment, a booklet will be created. One booster session (30minutes) will be planned after 4 weeks. Patients will follow the active treatment for 8 weeks.

Active physical therapy

Active physical therapy plus manual therapy OTHER

Participants in the Group 2 will receive active intervention plus 8 "Pompage" technique sessions (1 session/week). In these sessions (30 minutes each), "Pompage" technique will be performed by a physical therapist.

Active physical therapy plus manual therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male subjects aged between 18 and 80 years with non-specific neck pain lasting for more than 3 months.
• Informed consent

You may not qualify if:

• Subjects with acute or subacute neck pain;
• Subjects with specific etiology for neck pain (e.g. trauma, herniated disc, vertebral deformities, fractures);
• Subjects with central or peripheral neurological signs;
• Individuals with systemic diseases, neuromuscular diseases, rheumatic diseases, cognitive deficit, tumors;
• Subjects who underwent surgery within 6 months preceding enrollment;
• Subjects who underwent physical therapy treatment within 6 months preceding enrollment.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

University of Bologna - Italy

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Neck Pain; Musculoskeletal Diseases

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Paolo Pillastrini, Professor

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician (data analyst) will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: January 5, 2021
• Study Start: February 9, 2021
• Primary Completion: June 17, 2022
• Study Completion: August 31, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)