C0/1 Self-mobilization 3 Finger Cervical Rotation Scapular Squeeze
Treating clinicians fully reviewed this home exercise handout with each participant. Clinicians described and demonstrated each exercise, then asked the participant to perform the exercise in front of them. After all exercises had been instructed, the therapist asked the patient to demonstrate each exercise again with as few verbal cues as necessary.
Full Descriptions of Each Visit
Visit 1: Baseline and First Treatment
Informed consent was obtained followed by completion of self-report scales and the health record form. Clinicians reviewed this health record and completed objective evaluation excluding measurements taken by the blinded assessor. The initial goal was to screen for inclusion and exclusion criteria to ensure participants were eligible and safe to proceed. The blinded assessor entered the room to measure cervical ROM, jaw ROM, and PPT. The blinded assessor then left the area so that they could not hear or see which treatment group a patient had been randomized to. As noted above, suboccipital release, behavioral education, and exercise were standardized and consistent between groups. The first treatment provided to all participants was the suboccipital release/soft tissue work. Group One (cervical spine TJM group) received C0/1 and C2/3 TJMs as described previously. Group Two (minimal intervention group) received
sham manipulation (15 second hold before tissue tension) as described previously. After TJM/sham, all participants received education and instruction in the HEP utilizing the handouts for reference. Participants were given a chart to track compliance with the HEP. Blinded assessors then returned to take immediate response measurements. Final measurement of self- report NPRS and GROC were done at the completion of the visit.
Visit 2: 1-Week
Self-report scales were issued upon arrival. Measurements of cervical and jaw ROM and PPT were taken by the blinded assessor before intervention. Assessment included review of concerning symptoms, blood pressure and heart rate, and a general screen for nystagmus and vertebral artery. Barring no change in medical history or known contraindications, treatment began with 2 minutes of suboccipital release for both groups followed by cervical spine TJM or sham. All participants received review of behavioral education and home exercise instructions.
Visit 3: 2-Week
No measurement or self-report scale data was collected on this date. Assessment
included review of concerning symptoms, blood pressure and heart rate, and a general screen for nystagmus and vertebral artery. Barring no change in medical history or known
contraindications, treatment began with 2 minutes of suboccipital release for both groups followed by cervical spine TJM or sham. All participants received review of behavioral education and home exercise instructions.
Visit 4: 4-Week
No prescribed treatment was performed on this date, only assessment. Self-report scales were issued upon arrival. Measurements of ROM and PPT were taken by the blinded assessor. Clinicians debriefed participants explaining the intent of the research study, group allocation, and
potential impact of results. Continued treatment frequency, duration, and intervention plan were at the discretion of the treating clinician. Referral to another provider (medical, dental, or other) was done on this date if needed.
Sample Size Estimation/Power Analysis
Sample size estimations were completed before data collection began using G-Power, a free online downloadable program. An F-test family with analysis of variance (ANOVA): Repeated measures, within-between interaction protocol was selected. While it is optimal to power sample size estimations around a functional outcome measure, the limited use of
functional measures in this population created an obstacle. One study by Mulla106 et al utilized JFLS to assess differences between conventional PT (not well described) and the Rocabado exercise program with temporomandibular mobilization. The between group effect size reported for JFLS was d = 0.55.106 Another study by Cuccia152 et al utilizes an index that rates disability, however, this index is time consuming and not clinically applicable. In general, studies utilizing functional outcome tools had small sample sizes and/or large effect sizes, yielding smaller sample size estimations for this research project.
Examination of effect sizes surrounding mouth opening were examined next. Mouth opening is the most frequently reported objective outcome related to TMD and an important consideration in temporomandibular function. Mouth opening effect sizes ranged from d = 0.22 to 2.08. PPT is another commonly reported outcome in TMD related research. An examination of this outcome in a relevant study of upper cervical spine mobilization versus sham mobilization in TMD patients demonstrates effect sizes ranging from d = 1.040 to 2.129.23
One study analyzed 50 participants (25 per group) comparing multimodal intervention of cervical spine TJM, myofascial soft tissue work, and muscle energy techniques to oral
appliances, PT muscle stretching, relaxation exercises, and modalities.152 This study found a large effect size (d=1.01) for mouth opening at 6 months favoring the cervical TJM group. Another study compared mobilization of the upper cervical spine to sham mobilization following patients for 2 weeks.23 Large effect sizes were seen for pain (Visual Analogue Scale) and PPT favoring the mobilization group.
Several studies related to TMD intervention (cervical or other) did not report effect sizes but did provide enough information for these to be calculated. Other studies did not report or provide adequate detail to allow for calculation. Table 4 below summarizes outcomes relevant to this study as well as estimates of effect size. A * indicates the effect size was calculated by the PI of this project due to lack of description provided in the article. The last column represents the suggested sample size for this RCT based on calculations.
TABLE 3.3 REPORTEDAND CSALCULATED EFFECT SIZE ESTIMATESAND