Investigation of the Effects of Telerehabilitation Groups for Chronic Non-specific Low Back Pain.
Condition: Chronic Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The goal of this study is to investigate the efficacy of different internet based delivery
      methods for patients with chronic non-specific low back pain.

      The parameters we want to study is pain, disability, fear of movement, and quality of life.
    

Detailed description: 
      This study is a randomized control trial with two intervention groups and one control group
      with total sample size of 72:

        1. Real-time synchronized telerehabilitation program (STP). (n=24)

        2. Pre-recording non-synchronized telerehabilitation program (NSTP). (n=24)

        3. Home non-supervised control group (HCG). (n=24)

      Sample Size Calculation:

      An adequate sample size was calculated using G*power 3.1.9.7. Statistical test fixed effects
      one-way ANOVA, the probability for alpha error (α) at 0.05, large effect size f = 0.4, power
      = 0.8, and three groups. A total of 66 subjects was calculated as the minimum required sample
      size. In addition, based on previous studies a dropout rate was set at 10%. Hence, the total
      sample size was increased to 72. Therefore, each group will have 24 subjects (n=24).

      Method:

      Intervention:

      The three groups received a video conference education session. The content of the session
      was anatomy and physiology of the musculoskeletal structure, and kinesiology of the lumbar
      region. In addition, they were educated about the principles of pain, possible causes for the
      CNLBP, and how to manage CNLBP (correct posture and life modifications).

      Subjects in the STP and NSTP received the same exercises based on core stabilization and
      stretching but with different method.

        1. STP group will benefit from individual exercise session through real-time video calls,
           where the therapist demonstrates the exercises, and monitor the patient throughout the
           session.

        2. NSTP group will benefit from thoroughly instructional videos that describe every step of
           each exercise and will be followed up weekly through a video call to monitor compliance
           and answer questions.

        3. HCG group will receive a PDF file that includes the same exercises with written
           instructions. However, no further interventions nor follow-ups will be available for the
           HCG.

      Protocol:

      The exercise protocol (table1) will be as follow with total duration of 44 minutes:

      Warm-up (5 minutes): Head tilt, head rotation, shoulder circles, chest stretch, side bend,
      hip circles, torso twist, forward bend, Cat-cow.

      Stabilization exercises (25 minutes):

        1. Level one: Tabletop with single knee and hip flexion. 4-point kneeling with single leg
           stretch. Bridge. One leg stretch. Straight leg side lifts. Sit-ups with lumbar region
           fixed on the floor.

        2. Level two: Tabletop with step knee and hip flexion. 4-point kneeling with single-leg
           rise. Bridge with leg stretch. One leg stretch with knee extension. Straight leg side
           lifts with contralateral adduction. Sit-ups reach wrists to the knees.

        3. Level three: Tabletop with double knee and hip flexion. 4-point kneeling with
           contralateral arm and leg raise. Bridge with leg stretch and hold. One leg stretch hold
           and alternate knee extension. Straight leg side lifts adduct and hold. Sit-ups arms
           crossed over the chest.

             -  10 repetitions, 10 seconds rest intervals, 3 sets. Cooldown and stretching
                exercises (14 minutes): quadriceps stretch, kneeling hip flexor stretch, sitting
                adductor stretch, seated hip and ITB stretch, gluteal stretch (in prone position),
                piriformis stretch, hamstring-gastrocnemius stretch with a band, abdominal stretch,
                bend forward stretch.

                30 seconds hold for each exercise, 3 cycles.
    

Intervention name(s): Real-time synchronized telerehabilitation program (STP).; Pre-recording non-synchronized telerehabilitation program (NSTP); Home non-supervised control group (HCG)
Intervention type(s): Other; Other; Other
Intervention description(s): patient education, core stabilization exercises, strengthening exercises, stretching exercises; Pre-recording non-synchronized telerehabilitation program (NSTP); Home non-supervised control group (HCG)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment