Comparison Between Two Physical Therapy Treatments in Patients With Nonspecific Chronic Neck Pain
Condition: Non-specific Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

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.
    

Detailed description: 
      PROTOCOL OF INTERVENTIONS

      The intervention of group 1 (G1) is based on education and selective strengthening exercises
      for cervical muscles, and involves a protocol that must be performed by the patient for 8
      weeks. Halfway through the course (at the end of the fourth week) the physical therapist will
      carry out a reinforcement session, to monitor the clinical situation, motivate the patient
      and resolve any doubts (booster session).

      In group 2 (G2) the "Pompage" treatment will be added to this intervention.

      HOME EXERCISES: CONTENTS

      In the first session supervised by a physical therapist, lasting 30 minutes, the patient will
      be taught all the home exercises that he/she will have to perform and will be given:

        1. a hard copy with the exercise reminder;

        2. a diary for recording the daily execution of the exercises. The patients will be
           instructed to perform the exercises on a daily basis, without feeling pain. These
           exercises focus on strengthening the deep muscles of the neck; cranio-cervical flexor
           muscles and cervical extensors.

      PAIN EDUCATION: CONTENTS

      The educational intervention will take place verbally in a 30-minute session (explanation by
      the physical therapist), and will be supported by images, diagrams and summaries.

      During this intervention, the patient will be provided with information on chronic
      non-specific cervical pain and on "pain neuroscience education". The education session will
      focus on explaining the mechanisms through which the body perceives and interprets pain. The
      aim is to make the patient aware that experiencing pain does not necessarily mean that there
      is a damage on a part of the body. During this educational session, the physical therapist
      will try to encourage the patient to ask questions.

      At the end of this session, the patient will be given an information booklet on pain, with
      references to the themes just explored. This booklet provides further examples and ideas for
      elaborating and fixing the concepts learned during the session supervised by the physical
      therapist.

      MANUAL THERAPY: CONTENTS

      The treatment of group 2 (G2) combines the previous treatments with eight 30-minutes sessions
      of passive manual therapy, using the "Pompage" technique, carried out according to the
      indications shown in the monograph: "Zanella F, Vanti C. Pompage technique. The myofascial
      release. Piccin, Padua, 2015." The "Pompage" technique includes gradual and progressive soft
      tissue and fascia mobilization procedures, with the aim to obtain the myofascial release.
      This procedure is performed without provoking pain or forcing movements beyond the passive
      physiological range of motion. It consists of an alternation of rhythmic pressure and
      decompression, located at cervical joints and muscles (e.g. Trapezius Superior, Levator
      scapulae, Scalenus, Sterno-Cleido-Occipito-Mastoideus, etc.).
    

Intervention name(s): Active physical therapy (including both pain education and home exercises); Active physical therapy plus manual therapy
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neck pain; chronic neck pain; musculoskeletal disorder