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

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

Interventions

OTHER

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

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.

OTHER

Active physical therapy plus manual therapy

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.

Sponsors & Collaborators

• University of Bologna

  lead OTHER

Principal Investigators

• Paolo Pillastrini, Professor · University of Bologna

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-09

Primary Completion

2022-06-17

Completion

2022-08-31

Countries

• Italy

Study Locations